Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Month and Over
Gender	All

More Inclusion & Exclusion Criteria

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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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00026754
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Institute (NCI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	James L Gulley, M.D.
Principal Investigator Affiliation	National Cancer Institute (NCI)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Breast Cancer, Prostate Cancer, Lung Cancer, Sarcoma, Melanoma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: Cohort 1

Patients

: Cohort 2

Healthy Volunteers

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

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