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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923026
First received: June 17, 2009
Last updated: September 26, 2014
Last verified: September 2014
  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):

Primary Outcome Measures:
  • To provide long term follow up of patients previously enrolled on treatment protocols in the NCI Surgery Branch [ Time Frame: 15 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
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:   18 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923026

Contacts
Contact: Steven A Rosenberg, M.D. (301) 496-4164 sar@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
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: September 26, 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
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014