Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

Breast Cancer Clinical Trial

Official title:

Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00026754
• Other study ID #: 010129
• Secondary ID: 01-C-0129
• Status: Enrolling by invitation
• Start date: January 14, 2004

Study information

• Verified date: June 6, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Melanoma
• Prostate Cancer
• Sarcoma

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue for future research	Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research	10 years
Primary	Screening testing/results	Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values	10 years
Primary	Research sample collection	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	10 years
Primary	Numbers of screened patients and healthy volunteers	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.	10 years
Primary	Eligibility evaluations	Evaluate patient eligibility for participation in NCI/CCR research protocols	10 years

External Links

•   NIH Clinical Center Detailed Web Page