Healthy DonorsNCT00339911
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
An observational study of Healthy Donors, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Donors
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 1999to 13 Oct 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy NCI Frederick Cancer Research and Development Center employees@@@@@@
Who may be able to join
- 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
Who cannot join
- 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 risks associated with phlebotomy.
- History of syncope or other difficulty with venipuncture.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
NCI Frederick Cancer Research Center
Frederick, Maryland, 21702-1201
About this study
Official title: Collection and Distribution of Samples From Healthy Donors for In Vitro Research at NCI-Frederick
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.
Read more
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....
Read the detailed description
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, feces, nasopharyngeal swabs, 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.
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
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/ single cohort | Healthy NCI Frederick Cancer Research and Development Center employees |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish a centralized repository for the collection and distribution ofsamples
Collection of biospecimens
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Nov 1999
- Primary completion1 Oct 2030 (estimated)
- Study completion13 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy DonorsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Janelle Cortner, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339911
- Sponsor's protocol ID
- 999999046
- Other IDs
- OH99-C-N046
- Status last verified
- 9 Jun 2026
- First submitted
- 19 Jun 2006
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9249997McLeod 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.
PubMed 9767744