Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick

NCT00339911 | Enrolling By Invitation

• 2 other identifiers: 999999046OH99-C-N046
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Background

• NCI-Frederick scientists performing in vitro studies involving human specimens have a need for a reliable and consistent source of samples which protects the donor from research risks. Objective
• The purpose of this protocol is to establish a centralized repository for the collection and distribution of samples (either blood, buccal mucosal cells, semen, urine, or nail clippings) from paid, healthy volunteer donors for in vitro research conducted by NIH investigators located at NCI-Frederick and Ft. Detrick. Research will include, but are not limited to, genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and propagation of infectious agents, including HIV. Eligibility: Healthy NCI-Frederick employees and other NIH staff located at Ft. Detrick will be recruited. Potential donors will be excluded if screening indicates exposure to HIV, HTLV, Hepatitis C or Hepatitis B virus infection. Study Design: Investigators requesting to participate to the Research Donor Program (RDP) by receiving samples for research use will be required to submit a written memo of request, briefly describing the nature of the research and providing assurance that samples provided through this protocol will be used solely for in vitro research. These Investigators will receive samples that will be either anonymous or coded, depending on the specific need. Codes will be securely maintained and under no circumstances will donor identity be released to Investigators. Donors will receive financial compensation for their time, discomfort and inconvenience according to an established schedule; compensation for blood donation is based on the volume donated....

Conditions

Healthy Donors

Keywords

Repository; Phlebotomy; Venipuncture; Anemia; Occupational Health Services; Natural History

Outcome Measures

Primary Outcomes (1)

• Establish a centralized repository for the collection and distribution ofsamples

  Collection of biospecimens

  Ongoing

Study Arms (1)

1/ single cohort

Healthy NCI Frederick Cancer Research and Development Center employees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy NCI Frederick Cancer Research and Development Center employees@@@@@@

You may qualify if:

• Individuals must meet the following eligibility criteria to be entered into the RDP donor pool, as follows:
• Age 18 or older.
• Weight of 110 lb or greater.
• All subjects must have the ability and agree to participate fully and comply with the procedures of the protocol and provide informed consent.
• Registration for participation in semen donation is limited to males currently enrolled in the donor pool.
• Subjects must be NCI Frederick Employees

You may not qualify if:

• Individuals with any of the following will be excluded from the donor pool:
• History of chronic illness that might increase the risks associated with phlebotomy, including but not limited to heart, lung, or kidney disease
• Current acute illness.
• History of clotting disorders.
• Current medications which might increase the risk associated with phlebotomy.
• History of syncope or other difficulty with venipuncture.
• Anemia, as determined by hematocrit or hemoglobin.
• Hematocrit acceptable range for males: 40-51 percent.
• Hematocrit acceptable range for females: 34-46 percent.
• Hemoglobin acceptable range for males: 12.5-17.0 g/dl
• Hemoglobin acceptable range for females: 11.5-15.2 g/dl
• Positive blood test for exposure to HIV-1, HIV-2, HTLV-1, HTLV-2, or HCV or for HBV surface antigens.
• Individuals whose activities or conditions place them at high risk of HIV infection are asked not to donate.
• Males who qualify for participation in the donor pool will be excluded from participation in semen donation if they have knowingly had any injury, infection, or treatment performed that renders them incapable of producing sperm.
• Pregnancy: Pregnant women will not be allowed to enroll in this study because there is no benefit.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

NCI Frederick Cancer Research Center

Frederick, Maryland, 21702-1201, United States

Location

Related Publications (2)

• Merz JF, Sankar P, Taube SE, Livolsi V. Use of human tissues in research: clarifying clinician and researcher roles and information flows. J Investig Med. 1997 Jun;45(5):252-7. No abstract available.

  PMID: 9249997 BACKGROUND

• McLeod BC, Price TH, Owen H, Ciavarella D, Sniecinski I, Randels MJ, Smith JW. Frequency of immediate adverse effects associated with apheresis donation. Transfusion. 1998 Oct;38(10):938-43. doi: 10.1046/j.1537-2995.1998.381098440858.x.

  PMID: 9767744 BACKGROUND

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janelle Cortner, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: November 1, 1999
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 13, 2030
• Last Updated: May 7, 2026

Record last verified: 2025-07-09

Locations

US (1)