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Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies

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ClinicalTrials.gov Identifier: NCT00923026
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Background:

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.

Objective:

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.

Eligibility:

Patients must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol

Design

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

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.


Study Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow Up Protocol for Subjects Previously Enrolled in NCI Surgery Branch Studies
Study Start Date : June 3, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch [ Time Frame: 15 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Contacts
Contact: Steven A Rosenberg, M.D. (866) 820-4505 ncisbirc@mail.nih.gov

Locations
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    ncisbirc@mail.nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00923026     History of Changes
Other Study ID Numbers: 090161
09-C-0161
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: August 1, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Gene Therapy
Follow-Up
Delayed Toxicity
Adenocarcinoma
Melanoma
Neuroendocrine Tumors
Carcinoma

Additional relevant MeSH terms:
Melanoma
Adenocarcinoma
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial