Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
- Conditions
- Prostate CancerSarcomaBreast CancerLung CancerMelanoma
- Registration Number
- NCT00026754
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19522
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tissue for future research 10 years Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research
Numbers of screened patients and healthy volunteers 10 years Gather prospective information on the number of patients screened for a particular study and compare to those enrolled onto an interventional study or natural history study.
Screening testing/results 10 years Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values
Research sample collection 10 years 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 evaluations 10 years Evaluate patient eligibility for participation in NCI/CCR research protocols
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States