[c09aa8]: / clusters / 9knumclustersv2 / clust_2838.txt

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For inclusion into optional exploratory genetic and biomarker research, patients must fulfill the following criteria:\r\n* Provision of informed consent for genetic research\r\n* Provision of informed consent for biomarker research\r\n** If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient; the patient will not be excluded from other parts of the study
Patients must be given the opportunity to consent to the optional submission of tissue and blood for future research
PHASE I: Patients must have biopsiable disease and be amenable to having two research biopsies
For participants enrolling the phase IIa part of the study, accessible tumor lesion(s) for the purpose of research biopsy and willingness to undergo a research biopsy before treatment initiation and at the time of disease progression, as well as a single research blood sample before initiation of therapy; participants who undergo an attempted on-treatment research biopsy and in whom inadequate tissue is obtained are still eligible to receive protocol therapy; they will not be required to undergo a repeat research biopsy attempt
Lansky (for research participants =< years) or Karnofsky (for research participants > years) performance score >= at the time of study enrollment
Research participants with uncontrolled infection
Prior consent to have tumors used for unspecified future research
Pregnant women are excluded from this research; the male partner should use a condom
Logistical or psychological hindrance to participation in clinical research
Unwilling or unable to undergo research biopsy during the baseline (pre-surgical) clinic visit, or inadequate research biopsy obtained during the baseline (pre-surgical) clinic visit (determined by the gynecologic oncologist at the time of the subjects pelvic exam)
For inclusion in optional genetic research, the patient must provide a written informed consent for genetic research.
Logistical or psychological hindrance to participation in clinical research
Submission of research blood draw and/or tumor sample
Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
Research participants with any other active malignancies
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants must not require more than mg TID of dexamethasone during CAR T cell therapy
Current participation in another research or observational study.
Subject may also provide consent/assent for future correlative research; subjects may participate in the main trial without participating in future correlative research
Subject may also provide consent/assent for future correlative research; subjects may participate in the main trial without participating in future correlative research
Patients must agree to consent for their tumor samples to be used for generation of cellular research tools such as organoids
Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this clinical study protocol, so long as they consent to that part.
Patients must consent to pre and on treatment research biopsies
Amenable to regular follow-up (according to research policies) for at least years
Currently participating in an interventional research study related to HPV, except the Anal Cancer HSIL Outcomes Research (ANCHOR) study (NCT)
If a patient declines to participate in genetics research, there will be no penalty or loss of benefit to the patient; a patient who declines genetics research participation will not be excluded from any other aspect of the main study
All participants will undergo standard written informed consent procedures as dictated by the City of Hope Human Research Protections Office prior to performing any screening procedures that are not part of standard-of-care; informed consent will be obtained by the principal investigator, collaborating investigators, or other Institutional Review Board (IRB) designated personnel who will meet the training requirements established by the IRB; with the support of research personnel, he/she will explain the nature, duration, purpose of the study, potential risks, alternatives and potential benefits, and all other information contained in the informed consent document; in addition, they will review the experimental subject's bill of rights and the Health Insurance Portability and Accountability Act (HIPAA) research authorization form; prospective research participants will be informed that they may withdraw from the study at any time and for any reason without prejudice; prospective research participants will be afforded sufficient time to consider whether or not to participate in the research
Willing to donate blood for research at time points
Willing to donate tissue to research from the surgical specimen
Willing to donate blood for research at time points
Be willing and able to provide written informed consent/assent for the trial; the subject may also provide consent for future biomedical research; however, the subject may participate in the main trial without participating in future biomedical research
Group : consent to undergo research biopsies
The subject must be expected to have an adequate amount of residual tumor after their pre-operative research tumor tissue collection, such that their operative research tumor collection will also yield at least - research core biopsy specimens or the equivalent amount of tissue
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible; any history of myelodysplasia is excluded
Research participants must not require more than mg TID of dexamethasone during T cell therapy
Research participants with any non-malignant intercurrent illness which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it unwise to enter the research participant on protocol shall be ineligible
Research participants with any other active malignancies
Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
All research participants must have the ability to understand and willingness to sign a written informed consent or age appropriate assent for pediatric patients\r\n* Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
ELIGIBILITY TO UNDERGO LYMPHODEPLETION\r\nNote: evaluation should be performed no more than days prior to lymphodepletion\r\n* Research participant with central nervous system (CNS) leukemic involvement that is refractory to intrathecal chemotherapy and/or cranio-spinal radiation but effectively treated to completion remission (< white blood cell[WBC]/mm^ and no blast in cerebrospinal fluid [CSF]) is eligible to proceed with lymphodepletion\r\n* Research participants must have a donor or stem cells source identified for allogeneic transplantation, either related (/ or / allele matched or haploidentical), unrelated / or / allele match) donor, or cord blood stem cell source (at lease / matched)\r\n* Research participants with a response less than a CR or complete response with incomplete hematopoietic recovery (CRi) or detectable minimal residual disease (MRD) positive disease\r\n* Research participant has a released cryopreserved T cell product for CAR T cell infusion on approximately day \r\n* Research participant must be at least weeks out from having received the last dose of investigational agent\r\n* Karnofsky performance status (KPS) >= \r\n* Documented measurable or evaluable disease\r\n* Non hematological toxicity related to prior therapy must either have returned to =< grade , baseline, or deemed irreversible\r\n* Research participants of reproductive potential must agree to use and utilize and adequate method of contraception throughout treatment and for at least weeks after T cell infusion\r\n*If a research participant has undergone prior allogeneic stem cell transplant, he/she must be off all immunosuppressants for GVHD for at least days before beginning lymphodepletion\r\n* Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation % or higher on room air\r\n* Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension\r\n* Renal Function: calculated creatinine clearance (absolute value) of >= mL/minute or creatinine < . mg/dl or < times upper limit of normal for the research participant's age group\r\n* Liver Function: adequate liver function defined as total bilirubin =< . mg/dl \r\n* ALT and AST =< times the institutional upper limits of normal\r\n* Neurological: research participant without clinically significant encephalopathy/new focal deficits\r\n* Infectious diseases: no clinical evidence of uncontrolled active infectious process
ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED T CELLS\r\n* Research participants has undergone lymphodepletion\r\n* Pulmonary: not requiring supplemental oxygen or mechanical ventilation, oxygen saturation % or higher on room air\r\n* Cardiovascular: not requiring pressor support, no symptomatic cardiac arrhythmias, no acute coronary syndrome, or uncontrolled hypertension\r\n* Renal Function: calculated creatinine clearance (absolute value) of >= mL/minute or creatinine < . mg/dl or < times upper limit of normal for the research participant's age group\r\n* Liver Function: adequate liver function defined as total bilirubin =< . mg/dl\r\n* ALT and AST =< times the institutional upper limits of normal\r\n* Neurological: research participant without clinically significant encephalopathy/new focal deficits\r\n* Infectious diseases: no clinical evidence of uncontrolled active infectious process\r\n* Research participant must be off all anti-leukemic drugs, with the exception of the lymphodepleting regimens, at least days prior to CAR T cell infusion
Research participants with presence of other active malignancy; However, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
All subjects must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Research participants who received memory-enriched CDR(EQ):CD:zeta/EGFRt+ on IRB#
Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within weeks of screening; research participants with any signs of symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated within years with curative intent and in a complete remission are eligible
Research participants with confirmed st or higher relapse of disease by morphology, cytogenetics or molecular, or research participants with refractory or residual disease
All research participants must have the ability to understand and the willingness to sign a written informed consent\r\n* Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent in processed; however, the research participant is allowed to proceed with lymphodepletion and T cell infusion only after the translated full consent form is signed
Research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy\r\n* Note: Please note that the above criterion is not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible
At least one (usually up to ) gold fiducial placed in or around tumor, can be performed on the same day-after signing research informed consent
Actively being treated on any other therapeutic research study
Actively being treated on any other therapeutic research study
Actively being treated on any other therapeutic research study
Actively being treated on any other therapeutic research study
Actively being treated on any other research study
Research product must pass all release tests
Research participants with any uncontrolled illness including ongoing or active infections; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) positive based on testing performed within weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures or radiological evidence of infections
Research participants with presence of other active malignancy; however, research participants with history of prior malignancy treated with curative intent in complete remission are eligible
Agree to participate in research blood collection at different time periods ( ml = teaspoons)
Female research participants of childbearing age or males research participants of child fathering potential must agree to use safe contraceptive methods for the duration of the study and for months thereafter
Willingness to consent to research biopsy
Consent to research use of their BCC tissue
Unable to provide meaningful consent (i.e., impairment such that descriptions of the research are not clearly understood)
Must not have broken or irritated skin (as determined by the study nurses or delegated research staff)
Participation in a therapeutic research study within days of baseline
Unable to cooperate with research procedures
Research participants having any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within weeks of enrollment; research participants with any signs or symptoms of active infection, positive blood cultures, or radiological evidence of infections
Previously participated in any type of research study
Residence > miles from research site
Participants with a diagnosis of diabetes, unless they are able to provide a letter from a physician who will continue to monitor the participant during the research study
Patient participating in another biomedical/oral health interventional research study
Patient being treated at St. Jude Childrens Research Hospital
Participants must have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating National Cancer Institute (NCI) Community Oncology Research Program (NCORP) site
Participation in another research project that might interfere with completion of this study
PRE-TEST: Adults who can meet with Research Staff at Washington University in St. Louis in-person to complete study requirements
For patients that present to clinic to have a cervical excisional procedure (LEEP) for an already confirmed diagnosis of high grade cervical dysplasia, HRME imaging study will be performed and cervical biopsies might be taken for research purposes only; any extra biopsies taken will be for research purposes only and our research fund will pay them
Consent to the tissue Cancer Therapy and Research Center (CTRC) biorepository
Participants who exhibit severe psychological distress that prohibits them from participating in our intervention or long-term research program
Willing to donate mL of blood and endoscopic mucosal biopsies for research
Inability to come to Vanderbilt General Clinical Research Center (GCRC) for research procedures
Ability to participate fully in research elements for the duration of the trial.
Patients will be asked to consent to to extra biopsy samples to be used for this research project
Research biopsies in consenting patients with MPNST: will only be performed in patients >= years old
Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to the research PET scans; the serum pregnancy test must be performed within hours prior to the initial research PET imaging; a negative test will be necessary for such patients to undergo research PET imaging
The medical monitor, Dr. Lois Ayash, at minimum, may discuss the research protocol with the investigators, interview human subjects, and consult with others outside of the study about the research, shall have authority to stop a research protocol in progress, remove individual human subjects from a research protocol, and take whatever steps are necessary to protect the safety and well-being of human subjects until the Institutional Review Board (IRB) can assess the monitors report; shall have the responsibility to promptly report their observations and findings to the IRB or other designate official and the Human Research Protection Office at the Department of Defense; the monitor may also observe recruitment and enrollment procedures and the consent process for individuals, groups or units overseeing study interventions and interactions, reviewing monitoring plans and reports; overseeing data matching, data collection and analysis
Patient is participating in other research protocols at the time of the NaF/FDG PETMRI scan
OVARIAN CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
BREAST CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Ability to independently complete the study as assessed by the research staff
Attend the Cancer Therapy and Research Center (CTRC) breast clinic