Follow Up Protocol for Subjects Previously Enrolled in 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00923026|
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : June 13, 2018
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 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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies|
|Study Start Date :||June 3, 2009|
- To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch [ Time Frame: 15 years ]Long-term follow-up of patients who have participated in research studies in the NCI Surgery Branch
- Long-term follow-up for gene therapy studies [ Time Frame: 15 years ]Facilitate collection of long-term, follow-up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups.
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
|Contact: Steven A Rosenberg, M.D.||(866) 820-4505||IRC@nih.gov|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact NCI/Surgery Branch Recruitment Center 866-820-4505 firstname.lastname@example.org|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute (NCI)|