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NCT00001503 Clinical Trial

Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease

Breast Cancer Clinical Trial

Official title:
Follow-up for Patients Previously Enrolled on the Center for Cancer Research Protocols

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001503
Other study ID # 960071
Secondary ID 96-C-0071
Status Completed
Phase
First received
Last updated
Start date September 19, 1996
Est. completion date June 15, 2023

Study information
Verified date June 2023
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Other known NCT identifiers
  • NCT00296075

Recruitment information / eligibility
Status Completed
Enrollment 1031
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month and older
Eligibility - 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Institutes of Health Clinical Center Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Provision of a mechanism to follow selected CCR patients when their protocols have been terminated. 30 years
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