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
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Lymphoma
• Melanoma
• Ovarian Cancer
• Prostate Cancer

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

External Links

•   NIH Clinical Center Detailed Web Page