Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
- Conditions
- Carcinoma NOSMelanomaAdenocarcinomaNeuroendocrine Tumors
- Registration Number
- NCT00923026
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
Objective:
This study will allow participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Long-term follow-up Until time of death Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch
- Secondary Outcome Measures
Name Time Method Long-term follow-up for gene therapy studies 15 years Collection of long-term, follow-up information on subjects who have participated in gene transfer studies as required by the FDA and other regulatory groups
Survival Until time of death Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States