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Follow Up Protocol for Subjects Previously Enrolled on 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00923026
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2009
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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 on 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 National Cancer Institute Surgery Branch (NCI-SB) conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (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 long-term follow-up protocol is necessary to ensure the follow-up of these subjects.

Objective:

-Primary objective:

--Provide a mechanism for long-term follow-up of subjects who have participated in research studies in the NCI-SB.

Eligibility:

  • Age greater than or equal to 18 years.
  • Patient has been enrolled on an NCI-SB 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.

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Study Type : Observational
Actual Enrollment : 786 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Actual Study Start Date : June 15, 2009

Resource links provided by the National Library of Medicine


Group/Cohort
A/Gene Therapy
Patients who have received gene therapy
B/Non-Gene Therapy
Patients who have not received gene therapy



Primary Outcome Measures :
  1. Long-term follow-up [ Time Frame: Until time of death ]
    Long-term follow-up of subjects who have participated in research studies in the NCI Surgery Branch


Secondary Outcome Measures :
  1. Long-term follow-up for gene therapy studies [ Time Frame: 15 years ]
    Collection of long-term, follow-up information on subjects who have participated in gene transfer studies as required by the FDA and other regulatory groups

  2. Survival [ Time Frame: Until time of death ]
    Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects will have previously been enrolled on an NCI Surgery Branch treatment protocol. Patients who received gene therapy will be followed as required by the FDA.
Criteria
  • INCLUSION CRITERIA:
  • Age greater than or equal to 18 years.
  • Subjects who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Patients may participate in this protocol and, at the same time, participate in an active treatment study).

INCLUSION CRITERIA:

-Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of the investigational treatments administered on NCI-SB treatment protocols.


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


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven A Rosenberg, M.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00923026    
Other Study ID Numbers: 090161
09-C-0161
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: May 13, 2020
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:
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Melanoma
Adenocarcinoma
Neuroendocrine Tumors
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas