Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00923026|
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2009
Last Update Posted : June 11, 2020
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
|Condition or disease|
|Melanoma Adenocarcinoma Carcinoma NOS Neuroendocrine Tumors|
- 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 subjects.
--Provide a mechanism for long-term follow-up of subjects who have participated in research studies in the NCI-SB.
- Age greater than or equal to 18 years.
- Patient has been enrolled on an NCI-SB 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.
|Study Type :||Observational|
|Actual Enrollment :||786 participants|
|Official Title:||Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies|
|Actual Study Start Date :||June 15, 2009|
Patients who have received gene therapy
Patients who have not received gene therapy
- Long-term follow-up [ Time Frame: Until time of death ]Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch
- Long-term follow-up for gene therapy studies [ Time Frame: 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 [ Time Frame: Until time of death ]Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|