- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00923026
Follow Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Follow-Up Protocol for Subjects Previously Enrolled on NCI Surgery Branch Studies
Background:
The NCI Surgery Branch has developed experimental therapies that involve taking white blood cells from participants' 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 participants to be followed for up to 15 years following treatment on an NCI Surgery Branch Gene Therapy Trial as required by the FDA.
Eligibility:
Participants must have been enrolled on an NCI Surgery Branch Gene Therapy Protocol
Design
Participants will be followed with a physical examination and blood tests for up to 15 years as required by the FDA
Study Overview
Status
Conditions
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 participants.
Objective:
-Primary objective:
--Provide a mechanism for long-term follow-up of participants who have participated in research studies in the NCI-SB.
Eligibility:
- Age greater than or equal to 18 years.
- Participant has been enrolled on an NCI-SB treatment protocol.
Design:
- Participant will undergo physical exams, laboratory evaluation, imaging, or phone follow-up as clinically indicated.
- Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- Age greater than or equal to 18 years.
- Participants who have received treatment on an NCI-SB protocol, including gene therapy protocols. (Note: Participants may be enrolled on this protocol and, at the same time, participate in an active treatment study).
- For Cohort A:Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document. For Cohort B: Participant is able to provide informed consent.
INCLUSION CRITERIA:
-For Cohort B: 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
A/Gene Therapy
Patients who have received gene therapy
|
B/Non-Gene Therapy
Patients who have not received gene therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Until time of death
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
15 years
|
Survival
Time Frame: Until time of death
|
Follow subjects who have participated in research studies in the NCI Surgery Branch until time of death
|
Until time of death
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steven A Rosenberg, M.D., National Cancer Institute (NCI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090161
- 09-C-0161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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