Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 17, 2009

Keywords

ClinConnect Summary

This is a long-term follow-up study for people who previously took part in gene therapy trials run by the National Cancer Institute’s (NCI) Surgery Branch. There’s no new treatment being tested in this study. Instead, researchers will check on participants’ health for up to 15 years after their original trial participation, using physical exams, blood tests, imaging, or phone check-ins as needed. The goal is to help understand long-term safety and how people do over time after gene therapy studies, including information on survival.

Who can join? Adults 18 and older who were enrolled in an NCI Surgery Branch study, including those who received gene therapy (Cohort A) and those who did not (Cohort B). For Cohort A, a participant or their legally authorized representative can give consent; for Cohort B, the participant must be able to consent themselves. Exclusion for Cohort B includes pregnancy or plans to become pregnant due to potential risks. The study is based at the NIH Clinical Center in Bethesda, Maryland, and results may be shared with other researchers under certain conditions.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Age greater than or equal to 18 years.
• • Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study).
• • For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. For Cohort B: Participant is able to provide informed consent.
• EXCLUSION CRITERIA:
• • -For Cohort B: Individuals of child-bearing potential (IOCBP) who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.