Bethesda, Maryland 20892


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.

Study summary:

Background: - Patients and healthy volenteers 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. - Performing invasive procedures for the sole purpose of obtaining tissue specimens or biological fluids for research purposes is often not ethically justifiable in human subjects, yet these specimens are needed to advance our knowledge on a variety of cancers. Therefore, it is critical to obtain tissue and biological fluid samples for future research when procedures (e.g., surgical excision, diagnostic biopsy) are performed for clinical indications in this population. Invasive procedures will not be performed on healthy volunteers. 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. - Procure residual tissues or fluids that are remaining from tests or procedures that are performed for clinical indications (e.g., diagnosis or treatment of the cancer) during the screening process or during treatment and follow-up on a primary research protocol. These specimens will be stored for future research studies. 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 - 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 or after the screening process or at any time during treatment and follow-up on a primary NIH IRP research protocol will be stored. Residual biological fluids will be obtained during tests or procedures that are considered clinically indicated for the diagnosis or treatment of the patient's cancer or related disease. - 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.


- INCLUSION CRITERIA: - Patients and healthy volunteers who are being evaluated for protocols within the NIH Intramural Research Program. - All patients, healthy volunteers, their parent/guardians orLegally 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. - Patients, healthy volunteers, their parents/guardians or LAR can refuse to participate in the tissue procurement portion of this protocol and still participate in the screening eligibility for NIH IRP research trials EXCLUSION CRITERIA: None



Primary Contact:

Principal Investigator
Caryn Steakley, R.N.
National Cancer Institute (NCI)

Caryn Steakley, R.N.
Phone: (240) 760-6070

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Phone: (888) NCI-1937

Site Status: Recruiting

Data Source:

Date Processed: October 09, 2019

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