Eligibility Screening for the NIH Intramural Research Program Clinical Protocols

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.

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Study Overview

• Status: Completed
• Conditions: Melanoma; Sarcoma; Breast Cancer; Lung Cancer; Prostate Cancer

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 19522

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; Patients
Cohort 2; Healthy Volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Screening testing/results	Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values	10 years
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
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
Eligibility evaluations	Evaluate patient eligibility for participation in NCI/CCR research protocols	10 years

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: James L Gulley, M.D., National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2004
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: November 14, 2001
• First Submitted That Met QC Criteria: November 14, 2001
• First Posted (Estimated): November 15, 2001

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; HIV; Screening; HIV Infection; Scans; Laboratory Tests; Skin Disorders
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Neoplasms, Connective and Soft Tissue; Nevi and Melanomas; Skin Neoplasms; Melanoma; Sarcoma
• Other Study ID Numbers: 010129; 01-C-0129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD recorded in the medical record will be shared with intramural investigators upon request.
• IPD Sharing Time Frame: Clinical data available during the study and indefinitely.
• IPD Sharing Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No