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

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

Keywords

ClinConnect Summary

Background:

* Patients receiving care at the NIH Clinical Center are required to be enrolled on a clinical protocol.
* Following participation in a treatment protocol, it may be in the best interest of the patient to continue to be followed at the Clinical Center.
* The National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long-term follow-up are up to fifteen years for some products. As this time-period is frequently longer than studies are expected to be open, a long-term fo...

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.