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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00339911
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2006
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Healthy Donors

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, 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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Collection and Distribution of Samples From Healthy Donors for In Vitro Research at NCI-Frederick
Actual Study Start Date : November 1, 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Group/Cohort
1/ single cohort
Healthy NCI Frederick Cancer Research and Development Center employees



Primary Outcome Measures :
  1. Establish a centralized repository for the collection and distribution ofsamples [ Time Frame: Ongoing ]
    Collection of biospecimens



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy NCI Frederick Cancer Research and Development Center employees@@@@@@
Criteria
  • INCLUSION CRITERIA:

Individuals must meet the following eligibility criteria to be entered into the RDP donor pool, as follows:

  1. Age 18 or older.
  2. Weight of 110 lb or greater.
  3. All subjects must have the ability and agree to participate fully and comply with the procedures of the protocol and provide informed consent.
  4. Registration for participation in semen donation is limited to males currently enrolled in the donor pool.
  5. Subjects must be NCI Frederick Employees

EXCLUSION CRITERIA:

Individuals with any of the following will be excluded from the donor pool:

  1. History of chronic illness that might increase the risks associated with phlebotomy, including but not limited to heart, lung, or kidney disease
  2. Current acute illness.
  3. History of clotting disorders.
  4. Current medications which might increase the risk associated with phlebotomy.
  5. History of syncope or other difficulty with venipuncture.
  6. Anemia, as determined by hematocrit or hemoglobin.

    Hemotacrit acceptable range for males: 40-51 percent.

    Hemotacrit acceptable range for females: 34-46 percent.

  7. Hemoglobin acceptable range for males: 12.5-17.0 g/dl

    Hemoglobin acceptable range for females: 11.5-15.2 g/dl

  8. Positive blood test for exposure to HIV-1, HIV-2, HTLV-1, HTLV-2, or HCV or for HBV surface antigens.
  9. Individuals whose activities or conditions place them at high risk of HIV infection are asked not to donate.
  10. 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.
  11. Pregnancy: Pregnant women will not be allowed to enroll in this study because there is no benefit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339911


Locations
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United States, Maryland
NCI Frederick Cancer Research Center
Frederick, Maryland, United States, 21702-1201
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Janelle Cortner, Ph.D. National Cancer Institute (NCI)
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00339911    
Other Study ID Numbers: 999999046
OH99-C-N046
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: January 3, 2022
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Repository
Phlebotomy
Venipuncture
Anemia
Occupational Health Services
Natural History