Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies
This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923026
First received: June 17, 2009
Last updated: March 14, 2013
Last verified: December 2012
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Purpose
BACKGROUND:
- 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
OBJECTIVES:
-To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch
ELIGIBILITY:
-Enrollment on an NCI Surgery Branch treatment protocol
DESIGN:
-Patients will undergo physical exams, laboratory evaluation, imaging or phone follow up as required by the treatment protocol and/or as clinically indicated.
| Condition |
|---|
|
Melanoma Adenocarcinoma Carcinoma NOS Neuroendocrine Tumors |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
| Enrollment: | 374 |
| Study Start Date: | June 2009 |
BACKGROUND:
- 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
OBJECTIVES:
-To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch
ELIGIBILITY:
-Enrollment on an NCI Surgery Branch treatment protocol
DESIGN:
-Patients will undergo physical exams, laboratory evaluation, imaging or phone follow up as required by the treatment protocol and/or as clinically indicated.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- INCLUSION CRITERIA:
- Subjects who have received treatment on an NCI Surgery Branch protocol, including gene therapy protocols.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923026
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Steven A Rosenberg, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00923026 History of Changes |
| Other Study ID Numbers: | 090161, 09-C-0161 |
| Study First Received: | June 17, 2009 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Gene Therapy Follow-Up Delayed Toxicity Adenocarcinoma |
Melanoma Neuroendocrine Tumors Carcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Melanoma Neuroendocrine Tumors Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 21, 2013