Screening Patients for NCI Protocol Eligibility
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.
|Official Title:||Eligibility Screening and Tissue Procurement for the National Cancer Institute (NCI) Center for Cancer Research (CCR) Clinical Protocols|
|Study Start Date:||March 2001|
- Patients who are being evaluated for Center for Cancer Research 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.
- Evaluate patient eligibility for participation in NCI/CCR 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 NCI/CCR research protocol. These specimens will be stored for future research studies.
- Patients who are being evaluated for and treated on protocols within the CCR.
- 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 CCR 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 completes the screening process and is entered onto another study they may remain on this study to allow for screening for other trials in the future or for the tissue procurement portion of this trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026754
|Contact: Caryn Steakley, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Caryn Steakley, R.N.||National Cancer Institute (NCI)|