Clinical trial NCT00001503: Follow-up Protocol for Patients With Cancer/AIDS/Skin Disease
Official title: Follow-up for Patients Previously Enrolled on the Center for Cancer Research Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Ovarian Cancer
Prostate Cancer
Breast Cancer
Lymphoma
Keywords: Cancer
Late-effects
Survival
Follow-Up
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 1031
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: 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
timeFrame: 30 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: James L Gulley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: