Clinical trial NCT00026754: Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
Official title: Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Lung Cancer
Sarcoma
Melanoma
Keywords: Screening
Cancer
HIV Infection
Scans
Laboratory Tests
HIV
Skin Disorders
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-11-15
Enrollment: 19522
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.

Brief summary: The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.

Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.

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Detailed description: Background:

Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.

Objectives:

Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols.

Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values.

Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

Eligibility:

Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.

Design:

This protocol is not a research study of an investigational drug or device.

Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.

In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.

Tissues and biological fluids that are obtained during the screening process will be stored.

Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.

Eligibility criteria: * INCLUSION CRITERIA:
* Patients and healthy volunteers who are being evaluated for protocols within the NIH Intramural Research Program (IRP). Note: Participants must be \> 1 month of age.
* All patients or their parent/guardians or Legally Authorized Representative (LAR) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for research protocols. NOTE: It is expected that healthy adult volunteers have the capacity to consent (i.e., a LAR may not be used).

EXCLUSION CRITERIA:

None

Primary outcomes:
measure: Tissue for future research
timeFrame: 10 years
measure: Screening testing/results
timeFrame: 10 years
measure: Research sample collection
timeFrame: 10 years
measure: Numbers of screened patients and healthy volunteers
timeFrame: 10 years
measure: Eligibility evaluations
timeFrame: 10 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: