Collection and Distribution of Blood Samples From Healthy Donors for In Vitro Research at the NCI Frederick Cancer Research and Development Center

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00339911
First received: June 19, 2006
Last updated: June 26, 2014
Last verified: June 2014

June 19, 2006
June 26, 2014
October 1999
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Complete list of historical versions of study NCT00339911 on ClinicalTrials.gov Archive Site
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Collection and Distribution of Blood Samples From Healthy Donors for In Vitro Research at the NCI Frederick Cancer Research and Development Center
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick

Background:

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 NCI Frederick Investigators.

Objectives:

Research uses of normal donor samples obtained through this protocol will include but not be limited to genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and the propagation of infectious agents, including HIV.

Although samples may be used to screen for genetic polymorphisms, this protocol will not be used to conduct genetic screening, or other types of studies, specifically designed to reveal information of known clinical relevance or implication. Further, Investigators wishing to recontact donor(s) for repeated samples when preliminary work has given rise to a research question of potential clinical relevance will seek IRB guidance on whether a separate, specific protocol should be initiated.

Eligibility:

Healthy FCRDC employees will be recruited. Potential donors will be excluded if screening indicates exposure to HIV, HTLV or Hepatitis C virus or Hepatitis B virus infection.

Study Design:

Samples provided to Investigators 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.

The investigational nature of the studies in which their specimens will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and signed informed consent documents covering study participation and HIV testing will be obtained.

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.

Investigators requesting to participate in 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.

Whole blood will be collected by the standard phlebotomy technique of venipuncture of forearm veins.

Buccal mucosal cells will be collected by use of a sterile swab or brush or after oral rinse. Semen will be collected by self-masturbation at the donors homes.

Urine and nail clippings can be collected either in donors homes or at OHS.

Background:

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.

Objectives:

Research uses of normal donor samples obtained through this protocol will include but not be limited to genotype analysis, immune function studies, drug screening, vaccine development, method development, quality control testing of reagents, and the propagation of infectious agents, including HIV.

Although samples may be used to screen for genetic polymorphisms, this protocol will not be used to conduct genetic screening, or other types of studies, specifically designed to reveal information of known clinical relevance or implication. Further, Investigators wishing to recontact donor(s) for repeated samples when preliminary work has given rise to a research question of potential clinical relevance will seek IRB guidance on whether a separate, specific protocol should be initiated.

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 or Hepatitis C virus or Hepatitis B virus infection.

Study Design:

Samples provided to Investigators 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.

The investigational nature of the studies in which their specimens will be used, and the risks and discomforts of the donation process will be carefully explained to the donors, and signed informed consent documents covering study participation and HIV testing will be obtained.

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.

Investigators requesting to participate in 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.

Whole blood will be collected by the standard phlebotomy technique of venipuncture of forearm veins.

Buccal mucosal cells will be collected by use of a sterile swab or brush or after oral rinse. Semen will be collected by self-masturbation at the donors homes.

Urine and nail clippings can be collected either in donors homes or at OHS.

Observational
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Samples
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
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  • INCLUSION CRITERIA:

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

  1. Age 18 or older.
  2. Weight of 110 lb or greater.
  3. Registration for participation in semen donation is limited to males currently enrolled in the donor pool.

EXCLUSION CRITERIA:

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

  1. History of chronic illness which might increase the risk 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 CBC or hemotacrit:

    Hemotacrit acceptable range for males: 40-51 percent.

    Hemotacrit 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

  7. Positive blood test for exposure to HIV-1, HIV-2, HTLV-1, HTLV-2, or HCV or positive test for HBV surface antigens.
  8. Individuals will be shown a list of activities and conditions which place them at high risk of HIV infection and asked not to donate if any apply.
  9. 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.
Both
18 Years and older
Yes
Contact: Janelle Cortner, Ph.D. (301) 846-8712 jc328z@nih.gov
United States
 
NCT00339911
999999046, OH99-C-N046
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National Cancer Institute (NCI)
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Principal Investigator: Janelle Cortner, Ph.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP