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, 2014
Last verified: October 2013
  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: 493
Study Start Date: June 2009
Detailed Description:

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, 2014
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
Carcinoma
Melanoma
Neuroendocrine Tumors
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 23, 2014