Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease
June 15, 2023 updated by: National Cancer Institute (NCI)
Follow-up for Patients Previously Enrolled on the Center for Cancer Research Protocols
This protocol is to provide follow-up medical/surgical visits for DCS patients who are long term survivors and may not currently be a participant entered on an active research protocol.
No investigational treatments or standard treatments will be administered on this protocol.
Study Overview
Status
Completed
Conditions
Detailed Description
Background:
- Patients enrolled on CCR clinical protocols may require long term follow-up to assess outcome (e.g., survival) or the effects of prior therapy.
- Keeping the primary treatment protocols open after accrual is complete in order to follow patients for long term outcome is an administrative burden on investigators and the IRB.
Objectives:
-To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol.
Eligibility:
-Patients who were previously enrolled on a CCR protocol and who are not eligible for an active NCI intramural primary research protocol.
Design:
- The medical procedures/tests will be based on the patient's diagnosis, treatment and supporting clinical information. This is a follow-up study in which only standard tests and procedures are to be performed.
- Clinical information that is relevant to the patients prior protocols will be collected for research purposes.
- Procedures that entail more than minimal risk to the patient should not be performed for research purposes on this protocol.
Study Type
Observational
Enrollment (Actual)
1031
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients of any age who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.
Description
- ELIGIBILITY CRITERIA:
Patients of any age who were previously enrolled on a CCR protocol.
Not eligible for or unwilling to participate in an active NCI intramural primary research protocol.
CCR investigator decides it is in the best interests of the patient and the CC for the patient to be seen in follow-up visits at the NIH.
Patient or Legally Authorized Representative (LAR)/guardian is able to provide informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
1/All Patients
Patients who were previously enrolled on a CCR protocol and need follow-up by CCR Investigators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To provide follow-up for patients who are long term survivors previously enrolled Center for Cancer Research (CCR) trial but who may not currently be enrolled on a research protocol
Time Frame: 30 years
|
Provision of a mechanism to follow selected CCR patients when their protocols have been terminated.
|
30 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James L Gulley, M.D., National Cancer Institute (NCI)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 1996
Primary Completion (Actual)
June 15, 2023
Study Completion (Actual)
June 15, 2023
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
November 3, 1999
First Posted (Estimated)
November 4, 1999
Study Record Updates
Last Update Posted (Estimated)
June 16, 2023
Last Update Submitted That Met QC Criteria
June 15, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 960071
- 96-C-0071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
.All IPD recorded in the medical record will be shared with intramural investigators upon request.
IPD Sharing Time Frame
Clinical data available during the study and indefinitely.
IPD Sharing Access Criteria
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.