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
- Are there results?
- Not yet: the study is under way
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.
Show all 15Show fewer
- 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
- 29 Oct 2026
- First submitted
- 19 Jun 2006
- Last updated
- 5 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Distribution of Samples From Healthy Donors for In Vitro Research at NCI-Frederick
- ClinicalTrials.gov ID
- NCT00339911
- Acronym / sponsor ID
- 999999046
- Conditions
- Healthy Donors
- Keywords
- Repository, Phlebotomy, Venipuncture, Anemia, Occupational Health Services, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Nov 1999 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 13 Oct 2030 (estimated)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/ single cohort | – | –Healthy NCI Frederick Cancer Research and Development Center employees |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy NCI Frederick Cancer Research and Development Center employees@@@@@@
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish a centralized repository for the collection and distribution ofsamples
Time frame: Ongoing
Collection of biospecimens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 9249997Merz 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.
- Background: PubMed 9767744McLeod 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.
Related trials for Healthy Donors
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
COLLECT BLOOD/RESEARCH USE
Blood Donors, Research Subjects
RecruitingObservational study
Cytapheresis of Volunteer Donors
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janelle Cortner, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Donors, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a centralized repository for the collection and distribution ofsamples (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339911, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.