Screening Patients for NCI Protocol Eligibility
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|ClinicalTrials.gov Identifier: NCT00026754|
Recruitment Status : Recruiting
First Posted : November 15, 2001
Last Update Posted : February 14, 2018
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.
|Condition or disease|
|Breast Cancer Prostate Cancer Lung Cancer Sarcoma Melanoma|
- Patients and healthy volenteerswho 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.
- 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.
- Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||20000 participants|
|Official Title:||Eligibility Screening and Tissue Procurement for the National Cancer Institute Center for Cancer Research Clinical Protocols|
|Study Start Date :||March 21, 2001|
- Evaluate patient eligibility for participation in NCI/CCR research protocols [ Time Frame: 10 years ]
- Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values [ Time Frame: 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 [ Time Frame: 10 years ]
- Collect residual tissues or fluids that are remaining from tests or procedures that are performed for clinical indications (e.g., diagnosis or tx of the ca) during the screening process or during tx and follow-up on a primary NCI/CCR research pr... [ Time Frame: 10 years ]These specimens will be stored for future research studies
- 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. [ Time Frame: 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00026754
|Contact: Caryn Steakley, R.N.||(301) firstname.lastname@example.org|
|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)|