Able to operate the NovoTTF-100M device independently or with the help of a caregiver
Able to operate the NovoTTF-100L device independently or with the help of a caregiver
Ability to operate the NovoTTF-200A device independently or with caregiver aid
Patient must have an outpatient caregiver available
The patient has a caregiver for 28 days after dosing with C. novyi-NT
Caregiver: Must be considered the patient's primary caregiver
Caregiver: Age >= 18 years
The patient has a caregiver for 28 days after dosing.
Has a designated parent or caregiver who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
Parent/caregiver and patient (if 12 years and older) must be willing to use a cellular telephone to receive medication reminders via text messaging during study period
CAREGIVER: Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week
The patient must have an identified caregiver who is willing and able to oversee the training practice during the intervention period (ie, for 5-9 weeks starting approximately 3 months after completion of CRT)
A caregiver of a participating lung cancer survivor\r\n*An enrolled survivor may designate one primary caregiver to participate in the study; (a caregiver cannot participate without an enrolled survivor)
PARENT/CAREGIVER: One or both parents self-identify as Hispanic/Latino and the primary participating parent/caregiver is monolingual or bilingual Spanish speaking
PATIENT INCLUSION: Have an identified caregiver who is also willing to participate
Patient has a spouse/partner other or close family member who he/she defines as the primary caregiver
Patient/caregiver can provide informed consent
CAREGIVERS: Primary caregiver for study eligible patient
A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant
CAREGIVER ELIGIBILITY CRITERIA
(Caregiver participation) accompanied the patient to the clinic visit
(Caregiver participation) is identified by the patient as someone who is actively involved in their overall care
CAREGIVER: Family member/friend identified by the patient as the primary caregiver before and after surgery
CAREGIVER: >= 21 years
Parent/legal guardian/caregiver that speaks English available to assist in participant’s training
CAREGIVER: Unpaid individuals involved in assisting the cancer patient with activities of daily living and/or medical tasks
PATIENT AND CAREGIVER: Oriented to place, person, and time
PATIENT AND CAREGIVER: Have an active telephone service, either cellular or landline
A healthcare professional, a patient or caregiver in the Radiation Oncology Department at the University of Pennsylvania
Any healthcare professional or patient/caregiver not working in or being seen at Radiation Oncology Department at the University of Pennsylvania
PATIENTS: Having an informal family caregiver (spouse, romantic partner, adult child, or sibling) who is willing to participate. If patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria.
CAREGIVER: Spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the University of Pittsburgh Medical Center (UPMC)’s Liver Cancer Center (LCC)
CAREGIVER: Evidence of thought disorder, delusions, hallucinations, or suicidal ideation
INCLUSION CRITERIA FOR CAREGIVER PARTICIPANTS
Self-identifies as partner, spouse or caregiver of a patient who is eligible as a patient participant and who has consented to participate
EXCLUSION CRITERIA FOR CAREGIVER PARTICIPANTS
The patient for whom they are a caregiver does not consent to participate
Must have a caregiver or assistance at home who can assist with collecting physical therapy (PT) measures
Caregiver inclusion criteria:\r\n* Adults (>= 21)\r\n* Family member or friend of an eligible patient
PHASE 1: PARENT ELIGIBILITY: Caregiver of a pediatric cancer survivor age 18-25 who was primary caregiver at diagnosis
As per self-report, a current caregiver to a patient with any site or stage of cancer
Adequate caregiver support as defined by:\r\n* Single or multiple informal caregivers willing and able to provide 24 hour a day, seven day a week supervision of the transplant recipient in their home or \home-like\ environment\r\n* Caregiver willing and able to fulfill the basic stem cell transplant caregiver education requirements as determined by caregiver and healthcare team, including social worker
Both patient and caregiver willing to give and sign informed consent
Inadequate caregiver arrangements
CAREGIVER PARTICIPANTS:
Can identify at least one primary, adult caregiver
CAREGIVER: Can provide Informed consent
Lack of a caregiver
CAREGIVER:
Identified by patient as their primary caregiver
Meet standard clinical criteria for being a caregiver (able to drive and take care of patient)
Another parent or primary caregiver of the child has been enrolled in the study
Lack of a caregiver
PATIENTS ONLY: Having an informal caregiver (spouse, romantic partner, adult child, sibling, or friend) who is willing to participate; if patients do not have one consistent primary caregiver for the duration of the study, they may be accompanied to the yoga sessions by an alternate caregiver who meets eligibility criteria
Availability and willingness of a parent or caregiver to deliver acupressure for ages 5-17; for young adults ages 18-21 participation of a parent, close friend or family member/caregiver is preferred but not required
If patients have a caregiver, patients should agree to bring a caregiver to one of their hospital visits or have the caregiver schedule a separate study visit
CAREGIVER PARTICIPANTS:
Parents or adult primary caregiver (e.g., grandmother) of children ages 5 to 17 in treatment remission and has completed intensive therapy for ALL or AML
Parent/Caregiver: parents or adult primary caregiver (e.g., grandmother) of children treated for ALL or AML
ENTRY CRITERIA FOR CAREGIVERS: a caregiver can be anyone age 21 or over who is able to understand spoken English and understand the study process and provide informed consent; one caregiver for each patient will be eligible and must be chosen by the patient; for the purposes of this study, a caregiver is defined as a valued and trusted person in a patient’s life who is supportive in health care matters by providing valuable social support and/or direct assistive care; the caregiver accompanies the patient to medical appointments, is able to listen and give thoughtful advice and may be a family member, partner, friend, or professional caregiver
INCLUSION CRITERIA FOR CAREGIVERS: selected by the patient when asked if there is a “family member, partner, friend or caregiver (age 21 or older) with whom you discuss or who can be helpful in health-related matters”; patients who cannot identify such a person (“caregiver”) can be eligible for the study; a caregiver need not be someone who lives with the patient or provides direct hands-on care; a caregiver can be any person who provides support (in any way) to the patient
INCLUSION CRITERIA FOR CAREGIVERS: if a health care proxy signs consent for or with a patient, and wants to participate in the caregiver portion of the study, this same person will always be the caregiver selected; if a health care proxy does not want to enroll as a caregiver in the study or, if enrolled, chooses to stop their own participation in the caregiver portion of the study, but is able to assist the patient in completing the study, the patient can still participate; in other words, the health care proxy can choose NOT to participate in the caregiver portion of the study; this does not preclude the patient from participating in the patient portion of the study with the health care proxy’s assistance
CAREGIVER:
Primary nonprofessional, non-paid caregiver, as identified by the care recipient
CAREGIVER EXCLUSION:
Currently considers self to be a primary caregiver for anyone else other than children
For patients aged 13-17 years, have one caregiver willing and able to participate in the study
A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for transplant
Identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
Patients are eligible to enroll on this study with or without the enrollment of their caregiver
CAREGIVER INCLUSION CRITERIA:
Any caregiver is considered eligible for this study; the caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support
CAREGIVER EXCLUSION CRITERIA:
There are no exclusion criteria to caregiver participation in this study
FAMILY CAREGIVER: Chosen by a family member or friend with cancer to join them in participating in the MODEL Care study
FAMILY CAREGIVER: Willing and able to travel to the class location for 6 weekly 2-hour sessions
FAMILY CAREGIVER: Able and willing to consent
CAREGIVER: Relative or friend who is identified by the patient participant who plans to regularly accompany the patient to the majority of their clinic visits
CAREGIVER: Family caregiver must live with the patient or have in-person contact with him or her at least twice per week
Patient and caregiver must be willing to be videotaped
Subject has sufficient pleural fluid to allow safe insertion of an IPC. 7. Subject has negative pregnancy test if appropriate. 8. Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member or paid healthcare professional and applies to US sites only; UK subjects will have drainage managed by home-care nurses).
Patient and caregiver: A history of a psychiatric illness unrelated to the HSCT within the past 18 months
Patient and caregiver: Children under the age of 18 do not receive HSCTs in either program
Patient has a family caregiver who lives with him/her or has visited him/her in-person at least twice a week for the past month
Family caregiver identified by a lung cancer patient who meets the eligibility criteria listed above
Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month
Caregiver is willing to participate in this study
Patient’s caregiver is ineligible for the study or declines study participation
Caregiver does not have working phone service
FAMILY CAREGIVER ELIGIBILITY REQUIREMENTS:
Informal Caregivers will be accrued using the following inclusion criteria:\r\n* The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery\r\n* Able to read and understand English
Caregivers will be eligible for enrollment if they identify as the person who is the caregiver of a patient enrolled in a phase I oncology clinical trial
Caregivers will be eligible for enrollment if they identify as the person who is the caregiver of a patient diagnosed with advanced cancer (stage IV, solid tumor)
Family caregivers will need to be the primary family caregiver as identified by the lung cancer patient (ten caregivers from each of the following cancer care continuum points will be recruited)
An effort will always be made to recruit patient and caregiver pairs, but unpaired patients are also eligible
CAREGIVER: Have access to a mobile phone
CAREGIVER: Unpaired caregivers, including former caregivers of patients who are now deceased, are eligible for the focus group only
INFORMAL CAREGIVERS: The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
CAREGIVERS ONLY: Must be primary caregiver of the patient
Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child)
A second parent/caregiver will be eligible to participate in the study if they are at least 18 years old and have at least on child under age 18 who is living in the same household and participating in the study
Self-identifies as the child's main caregiver
Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary
As this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation
CHILD: Has a caregiver, >= 18 years of age that is willing to participate in the study
CAREGIVER/PARENT: Ability of caregiver to read and speak English
CAREGIVER: Accompanying an MSK patient undergoing treatment for cancer by one of the consented HCPs as per the HCP and/or EMR
Available caregiver
Patient or parent/guardian capable of providing informed consent
Patient or parent/guardian capable of providing informed consent
Willing to and capable of providing written informed consent prior to any study related procedures
Patients must be capable of understanding and providing a written informed consent
Must be capable of providing informed consent
Caregiver capable of providing post-HCT care
Adult donors must be an HLA 4-8/8 match with the patient and must be capable of providing informed consent
Capable of providing informed consent and complying with trial procedures.
Capable of providing informed consent
Capable of informed consent
Capability of providing informed consent
Patients must be capable of informed consent
Capable of providing informed consent and complying with trial procedures.
DONOR: Adult donors must be must be a HLA 3-5/6 related haploidentical match with the patient and must be capable of providing informed consent
The subject must be capable of understanding the investigational nature, potential risks and benefits of the study and capable of providing valid informed consent. The subject must provide study specific informed consent prior to any protocol procedures that are not a part of standard care, including consent for assessment of HLA-A2 status, mandatory tissue submission for MAGE-A3 analysis and correlative studies.
Patient or parent/guardian capable of providing informed consent
Patients capable of providing written, informed consent
Patient (or legal representative where appropriate) must be capable of providing written informed consent.
Capable of providing informed consent and complying with trial procedures.
Capable of providing informed consent and complying with trial procedures.
Patients must be capable of providing informed consent and must be willing to provide written informed consent prior to the start of any study-specific procedures.
Capable of providing informed consent
Providing informed consent
DCG: Is capable of providing informed consent
Providing informed consent
Capable of providing informed consent
Participants must be capable of providing written informed consent for study participation
Capable of informed consent
Willing to and capable of providing written informed consent prior to any study related procedures
Be capable of providing informed consent and demonstrate a willingness to comply with all the study procedures and visits
The patient must be considered legally capable of providing his or her own consent for participation in this study
All patients and/or their parent or legal guardian must sign a written informed consent
Any perceived inability to directly (and without the means of a legal guardian) provide informed consent
Signed informed consent MUST be obtained from patient or parent/legal guardian (if patient is less than 18 years of age). Consent must be signed prior to any study procedures and study entry
Patient, parent, or legal guardian must be able to understand and be willing to provide informed consent
Patient and/or legal guardian must sign informed consent for HSCT.
In the haplo cohort, the donor and/or legal guardian must be able to sign informed consent documents.
The subject or their legal guardian be willing and able to provide written informed consent for the trial
No written consent of the patient or his/her parents or legal guardian
Able to provide signed informed consent (or consent provided by legal guardian for pediatric patients, as applicable)
Cognitively impaired patients who cannot give informed consent and do not have a legal guardian
The patient or their legal guardian must give their informed consent
Patient, parent, or legal guardian must be able to understand and willing to provide informed consent
All patients and/or a legal guardian must sign institutionally approved written informed consent and assent documents
Patient has a psychiatric illness that would prevent the patient or legal guardian or representative from giving informed consent and/or assent.
The patient or legal guardian must provide written informed consent
Must have reached legal age to consent.
LYMPHODEPLETION: Written informed consent for the main study signed by subject or legal guardian of a pediatric subject
Patient and/or legal guardian must sign informed consent for BMT
Patients or parents/legal guardian must be able to give informed consent
Signed informed consent by patient and/or parents or legal guardian
For the patient or parent/legal guardian to be able to comply with treatment plan, study procedures and follow-up examinations
Ability to swallow pills, or liquid formulation and for patient or parent/legal guardian to keep an accurate medication record
Patient or legal guardian must provide written informed consent
Subject or a legal guardian is able to voluntarily provide written informed consent.
Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
Participants or their legal guardian must sign consent prior to the initiation of radiation therapy
Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects; legal guardians will be given a signed copy of the consent form; note: for inclusion on biology studies after enucleation, the patient or his/her legal guardian, as appropriate, must provide written informed consent for SJRET6 protocol within 60 days of the removal of the tissue (eye) sample
Patient or patient’s guardian is able to give informed consent
Patient and/or legal guardian must be able to sign informed consent.
Subject (or legal guardian) must sign a written informed consent in accordance with institutional guidelines
Subjects or their legal guardian must sign a written informed consent in accordance with institutional guidelines
History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (Note: Consent may not be obtained by means of a legal guardian)
Any history of HIV-1 associated encephalopathy; dementia of any kind; seizures in the past 12 months; any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian)
Patient or legal guardian must be able to give informed consent
Lack of parents'/guardian's informed consent for children who are minors.
They or their legal guardian must give their informed consent
Ability by patient or parent/legal guardian (for patients under 18 years of age) to understand a written informed consent document, and the willingness to sign it
All patients and/or a legal guardian must sign institutionally approved written informed consent document
Signed informed consent by patient and/or parents or legal guardian
Ability to give informed consent; for recipients and donors < 18 years of age, their legal guardian must give informed consent; pediatric patients will be included in an age appropriate discussion in accordance with institutional guidelines
Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document
Participants or their legal guardian must sign consent prior to the initiation of radiation therapy
The patient or legal guardian must be able to comprehend the informed consent form and sign prior to patient enrollment
The patient or legal guardian is able to give informed consent
Patient or legal guardian must be able to give informed consent
Ability to give informed consent; for patients < 18 years of age their legal guardian must give informed consent; pediatric patients will be included in age-appropriate discussion in order to obtain verbal assent
Patient or his or her legal representatives must give written informed consent and privacy authorization prior to participation in the study.
Informed consent explained to and signed by parent/legal guardian or patient if the patient is >= 18 years
Patient or legal guardian has signed informed consent.
Parents or legal guardian signed-written informed consent
Patient and/or legal guardian able to provide signed informed consent
Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian
For donors < 18 years of age, their legal guardian must give informed consent, the donor must give written assent
Patient or legal guardian willing to sign consent for skin biopsies and phlebotomy
Patients who have dementia or a legal guardian
Parent or legal guardian consent
Parent/legal guardian willing and capable of signing written informed consent
Parent/legal guardian expected to be available for entire study
Parent/legal guardian can be reached by telephone or email
Ability to give informed consent for patients greater than 18 years of age. For patients less than 18 years of age the legal guardian must give informed consent.
Individuals able to give informed consent, or a signature from a designated health care proxy or legal guardian
Signed document of informed consent completed by the parent or legal guardian
Ability to understand and the willingness of the patient, parent or legal guardian to provide informed consent
Patient or legal parent/guardian unable to provide informed consent
Able to understand and willing to consent or assent to the research proposed, along with consent of legal guardian(s) if applicable
Patient and/or legal guardian able and willing to provide informed consent
Procurement: Informed consent explained to, understood by and signed by patient. Patient given copy of informed consent
Informed consent explained to, understood by and signed by patient. Patient given copy of informed consent
PROCUREMENT INCLUSION CRITERIA: Informed consent explained to, understood by and signed by patient; patient given copy of informed consent
Informed consent explained to, understood by and signed by patient; patient given copy of informed consent
INCLUSION - PROCUREMENT: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
INCLUSION - TREATMENT: Informed consent explained to, understood by, and signed by patient/guardian; patient/guardian given copy of informed consent
INCLUSION - PROCUREMENT: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given a copy of informed consent
INCLUSION - INFUSION: Informed consent explained to, understood and signed by patient/guardian; patient/guardian given a copy of informed consent
PROCUREMENT INCLUSION: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
TREATMENT INCLUSION: Informed consent explained to, understood by and signed by patient or guardian; patient or guardian given a copy of the informed consent form
Signed donor and patient/guardian informed consent;
PROCUREMENT INCLUSION CRITERIA: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
INCLUSION - PROCUREMENT: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
INCLUSION - TREATMENT: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
PRIOR TO CELL PROCUREMENT: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form for procurement
PRIOR TO LYMPHODEPLETION: Informed consent explained to, understood by and signed by the patient or legal guardian for pediatric patients; patient and/or legal guardian given a copy of informed consent form
AT THE TIME OF PROCUREMENT: Informed consent explained to, understood by and signed by subject/guardian; subject/guardian given copy of informed consent
AT THE TIME OF INFUSION: Informed consent explained to, understood by and signed by research subjects/guardian; subject/guardian given copy of informed consent
PROCUREMENT: Informed consent explained to and signed by patient/guardian able to give informed consent and patient given a copy
TREATMENT: Informed consent explained to and signed by patient/guardian able to give informed consent and patient given a copy
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy
Informed consent explained to and signed by patient or parent/guardian able to give informed consent and given a copy
Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
AT THE TIME OF PROCUREMENT: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
AT THE TIME OF INFUSION: Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent
Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Informed consent explained to, understood by and signed by subject/guardian; subject/guardian given copy of informed consent
Legal incapacity or limited legal capacity.
Subject has legal incapacity or limited legal capacity.
The subject has legal incapacity or limited legal capacity.
Legal incapacity/limited legal capacity for providing informed consent.
The subject has legal incapacity or limited legal capacity.
Patients who are imprisoned or under legal guardianship
Legal incapacity or limited legal capacity
Legal incapacity or limited legal capacity
Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian
Legal incapacity or limited legal capacity
Legal incapacity or limited legal capacity
Legal incapacity or limited legal capacity
Legal incapacity or limited legal capacity
Legal incapacity or limited legal capacity.
Subject is under legal custodianship
Legal incapacity or limited legal capacity
Legal incapacity
Inclusion Criteria:\n\n        Specific criteria for patients who continue treatment as well as safety and survival\n        follow-up in the extension study:\n\n          -  Eligible for continuing or crossing over to atezolizumab-based therapy at the time of\n             the parent-study closure as per the parent study or eligible for continuing the\n             comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the\n             parent-study closure as per the parent study\n\n          -  First dose of study treatment in the extension study will be received within the\n             treatment interruption period allowed by the parent study\n\n          -  Continue to benefit from atezolizumab-based study treatment or from the comparator at\n             the time of parent-study closure as assessed by the investigator\n\n          -  Negative serum pregnancy test within 7 days prior to start of study treatment in women\n             of childbearing potential\n\n        Specific criteria for patients who do not continue treatment in the extension study and/or\n        receive commercially available atezolizumab (Tecentriq) outside this extension study and\n        continue safety and survival follow-up only in the extension study:\n\n        - Discontinuation of atezolizumab-based therapy in parent study and in survival follow up\n        at the time of parent study closure, or eligible for continuing or crossing over to\n        atezolizumab-based therapy as per the parent protocol and have access to commercially\n        available atezolizumab (Tecentriq) outside this extension study at the time of the\n        parent-study closure\n\n        Exclusion Criteria:\n\n        Specific criteria for patients who continue treatment as well as safety and survival\n        follow-up in the extension study:\n\n          -  Meet of any of the study treatment discontinuation criteria specified in the parent\n             study at the time of enrollment in the extension study\n\n          -  Study treatment is commercially marketed in the patient's country for the patient\n             specific disease and is accessible to the patient\n\n          -  Time between the last dose of treatment received in parent study and first dose in\n             extension study is longer than the interruption period allowed in the parent study\n\n          -  Treatment with any anti-cancer treatment (other than treatment permitted in the parent\n             study) during the time between last treatment in the parent study and the first dose\n             of study treatment in the extension study\n\n          -  Permanent discontinuation of atezolizumab for any reason during the parent study or\n             during the time between last treatment in the parent study and the first dose of study\n             treatment in the extension study (if applicable)\n\n          -  Any unresolved or irreversible toxicities during the parent study that required\n             permanent discontinuation of study treatment, in accordance to the parent study or\n             local prescribing information\n\n          -  Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to\n             (<=) 1 from the parent study or during the time between last treatment in the parent\n             study and the first dose of study treatment in the extension study\n\n          -  Any serious uncontrolled concomitant disease that would contraindicate the use of\n             study treatment at the time of the extension study or that would place the participant\n             at high risk for treatment-related complications\n\n          -  Concurrent participation in any therapeutic clinical trial (other than the parent\n             study)\n\n        Specific criteria for patients who do not continue treatment in the extension study and/or\n        receive commercially available atezolizumab (Tecentriq) outside this extension study and\n        continue safety and survival follow-up only in the extension study:\n\n        - Discontinuation of comparator in parent study and in survival follow-up at the time of\n        parent study closure
Ongoing SAEs from the parent study
Patient, parent/guardian able to give informed consent
Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent/assent document; informed consent/assent must be signed prior to registration on this study
The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document, inclusive of assent where appropriate, according to institutional guidelines
INCLUSION CRITERIA FOR STRATUM C: The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document, inclusive of assent where appropriate, according to institutional guidelines
ELIGIBILITY FOR SCREENING: Informed consent (and assent as applicable) obtained from patient/guardian
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Informed consent (and assent as applicable) signed by patient/guardian
Willing to give informed consent\r\n* A parent or guardian must be available for giving consent for pediatric subjects under 18 years of age
Written informed consent and/or signed assent from patient, parent or guardian.
Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and receive T-cell infusion
All patients or legally responsible parent or guardian must have the ability to understand and willingness to sign a written informed consent.
A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate
Documented informed consent/assent of the participant or legally responsible guardian
Voluntary written consent (adult; legally authorized representative on behalf of cognitively impaired adult; or parent/guardian with presentation of the minor information sheet, if appropriate)
Subject/parental/guardian permission (informed consent), and child assent for subjects >= 7 years
PART 2 GROUP 1 INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
PART 2 GROUP 2A INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
PART 2 GROUP 3 INCLUSION CRITERIA: All subjects or a parent/guardian must sign written informed consent
Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
Voluntary written consent (adult or parent/guardian with presentation of the minor information sheet, if appropriate)
Ability for patient (and if applicable parent or legal guardian) to understand and the willingness to sign a written informed consent document, or for a parent or legal guardian to give assent for those cases where a very young patient is unable to understand or sign the consent
Appropriate written consent – adult or parent/guardian if patient is < 18 years of age and minor information sheet if patient is > 8 years of age
Written informed consent from patient and/or signed assent from patient, parent or guardian
Written and signed informed consent from the parent(s) or legal representative (guardian) and assent from the minor participant. Written informed consent from subjects ?18 years.
Voluntary written consent with appropriate parent/guardian consent and minor information sheet for participants < 18 years of age
Research participant or parent/legal guardian must agree to participate in long-term follow-up for up to 15 years, if they are enrolled in the study and receive T-cell infusion
Written informed consent and/or signed assent line from patient, parent or guardian
Written informed consent and/or signed assent line from patient, parent or guardian
Patient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen years
Patients 18 years or older will provide written consent. A parent or legal guardian of a patient <18 years of age will provide informed consent and patients 11 to 18 years of age will provide written assent or as per participating institutional policy.
Patient or patient’s legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant’s age is at least seven and less than eighteen years
Written informed consent and/or signed assent line from patient, parent or guardian
Informed consent and assent (as applicable) obtained from parent/guardian and child
Signed informed consent by the patient or the patient's parent or guardian for patients who are minors
Written informed consent and/or assent from patient, parent or guardian.
All patients >= 18 years must sign a written informed consent; patients < 18 years old must provide assent, and the parent or legal guardian must sign the written informed consent
Inclusion Criteria:\n\n          1. Randomized in the parent study, PCYC-1115-CA\n\n          2. Informed consent for Study PCYC-1116-CA\n\n          3. IRC-confirmed PD in the parent study PCYC-1115-CA or closure of the parent study\n\n        Exclusion Criteria:
DONOR: Children greater than or equal to 12 years of age who have not provided informed assent in the presence of a parent and an attending physician who is not a member of the recipient’s care team
Written informed consent/assent before any study-specific screening procedures. For pediatric patients, consent will be obtained from parent(s) or legal guardian(s) and the signature of at least 1 parent or guardian will be required. Investigators will also obtain assent of patients according to local, regional or national guidelines.
Subject (and/or parent/guardian for subject who otherwise is unable to provide independent consent, if acceptable to and approved by the site and/or site's IRB) must be willing to give written informed consent and be able to adhere to dose and visit schedules.
Children not in the care or custody of a biological parent, adoptive parent, appointed legal guardian, or legally appointed foster care.
To the best of his or her (or parent/guardian) knowledge, willing and able to participate in all required study activities for the duration of the study.
Written patient assent (as appropriate).
Written informed consent and/or signed assent line from patient, parent or guardian
If under age 18, parent(s) or guardian(s) able to participate in informed consent and initial assessment (unless the participant provides evidence of emancipated status)
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
Patient or patient's legal representative, parent(s) or guardian should provide written informed consent; assent of a minor if participant's age is at least seven and less than eighteen years
A parent (referred to as “parent” in this proposal and includes a parent or legal guardian) of a patient age 3 to 17 years of age who is newly diagnosed with any type of malignant disease on an inpatient oncology unit
IC from the subject or assent from the subject and consent from a parent or guardian, if the subject is < 18 years of age
Patient or parent(s)/legal guardian(s) is able and willing to provide informed consent; assent will be obtained per local institutional policy; subjects who turn 18 during the course of the study will be consented at that time of their next visit by a member of the research staff
If a biological parent lives in the home, and is physically well themselves, this person must be the co-parent
If a biological parent does not live in the home (or has died), the co-parent does not have to be a biological parent; therefore, co-parents may be step-parents, lesbian, gay, bi-sexual or transgender (LGBT) partners, grandparents, aunts, uncles, etc if they otherwise meet eligibility criteria
The patient and co-parent must agree to focus on the same child throughout the study and consent to have the child participate before the child's assent will be sought
Informed consent must be obtained prior to any study-related procedures; consent will be obtained from a parent or guardian of eligible subjects, or the patient if >= 18 years old; oral assent will be obtained from minor subjects >= 7 years old, unless more stringent requirements are imposed by a site’s local institutional review board
Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)
SUBJECT: Must have a parent or legal guardian willing to complete the parent proxy behavioral questionnaires and help their child participate in the study procedures at home.
PARENT OR GUARDIAN: Parent or Guardian of participating subject.
PARENT OR GUARDIAN: Parent or guardian of an ineligible subject.
Biological or adoptive parent or stepparent as reported in the child's medical record or by parent report
SUPPORT PROVIDER: Has been identified by the bereaved parent participant as a support or someone important to bereaved parent
Patient aged 12-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation
One consistent parent is willing and available to participate in all parent and evaluation sessions
Written informed consent and/or signed assent line from patient, parent or guardian
Patient or parent/legal guardian or representative has a psychiatric illness that would prevent the patient or parent/legal guardian or representative from giving informed consent and/or assent.
Signed written informed consent by parent(s)/legal guardians of the pediatric patient in compliance with the local laws and regulations. In addition signed children's assent form according to local requirements.
Patient, parent/guardian able to give informed consent
Signed informed consent by subject (age >= 18 years) or by parent/guardian (subject age < 18 years); information will be provided to potential subjects and their parents/guardians (as appropriate) by oral discussion with opportunity for question and answer and the written informed consent document; subjects less than 18 years of age capable of giving assent will be included in these discussions and will be asked for written assent on the same document as the parents/guardians give consent; if feasible, both parents (or guardians) will be included in these discussions and will be asked to sign the written consent document; if a second parent or guardian is unavailable, this will be explained in writing on the written consent document; if subjects age 18 years or older are unable to provide informed consent, then they will not be enrolled in this study
In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate
In this pediatric & adult study, the participant or parent/guardian is consented, and the patient when a minor is given an assent form and involved in the discussion as appropriate
Informed consent or assent signed by study subject or parent/guardian according to institutional guidelines
All patients or their legal guardians (if the patient is < 18 years of age) must sign a document of informed consent indicating their awareness of the investigational nature and the risks of this study; when appropriate, the minor patient will be asked for oral assent; the parent or guardian will sign the consent form on the designated line attesting to the fact that the minor has given assent
Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or blood samples used for research as outlined in this protocol, or, consent from a parent/guardian with assent from the child
Informed Consent: Written informed consent must be obtained from subject or parent/legal guardian prior to enrollment. Assent, when appropriate, will be obtained according to institutional guidelines
Inability or unwillingness of research participant or legal guardian to consent
Inability or unwillingness of research participant or legal guardian to consent
Inability or unwillingness of legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
Research participant or legal guardian/representative must be willing to give written informed consent
Inability or unwillingness or research participant or legal guardian/representative to give written informed consent
Research participant or legal guardian/representative is able and willing to give written informed consent
Inability or unwillingness of research participant or legal guardian or representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent
EXCLUSION CRITERIA FOR OPEN-ACCESS: Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent