Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.
This study will allow patients to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Patients must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Patients will be followed with a physical examination and blood tests for up to 15 years as required by the FDA
|Study Design:||Time Perspective: Prospective|
|Official Title:||Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies|
- To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2009|
- Patients receiving care at the NIH Clinical Center are required to be enrolled in 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 NCI Surgery Branch conducts clinical trials utilizing gene transfer. The current 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 protocol is necessary to ensure the necessary follow up of these subjects
-To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch
-Enrollment on an NCI Surgery Branch treatment protocol
-Patients will undergo physical exams, laboratory evaluation, imaging or phone follow up as required by the treatment protocol and/or as clinically indicated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923026
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|