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Trial record 47 of 65 for:    HTLV

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

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ClinicalTrials.gov Identifier: NCT00339911
Recruitment Status : Enrolling by invitation
First Posted : June 21, 2006
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

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.


Condition or disease
Healthy Donors

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 838 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Study Start Date : October 19, 1999



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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

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
United States, Maryland
NCI Frederick Cancer Research Center
Frederick, Maryland, United States, 21702-1201
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Janelle Cortner, Ph.D. National Cancer Institute (NCI)

Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00339911     History of Changes
Other Study ID Numbers: 999999046
OH99-C-N046
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: April 3, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Repository
Phlebotomy
Venipuncture
Anemia
Occupational Health Services