[c09aa8]: / clusters / ordered9kclusters / clust_1435.txt

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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