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

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 follow-up protocol is necessary to ensure the follow-up of these participants.

Objective:

-Primary objective:

--Provide a mechanism for long-term follow-up of participants who have participated in research studies in the NCI-SB.

Eligibility:

• Age greater than or equal to 18 years.
• Participant has been enrolled on an NCI-SB treatment protocol.

Design:

• Participant will undergo physical exams, laboratory evaluation, imaging, or phone follow-up as clinically indicated.
• Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.

• 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.