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Clinical Trials/NCT00339911
NCT00339911
Enrolling By Invitation
Not Applicable

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

National Cancer Institute (NCI)1 site in 1 country1,200 target enrollmentNovember 1, 1999
ConditionsHealthy Donors

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Donors
Sponsor
National Cancer Institute (NCI)
Enrollment
1200
Locations
1
Primary Endpoint
Establish a centralized repository for the collection and distribution ofsamples
Status
Enrolling By Invitation
Last Updated
4 months ago

Overview

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.

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. 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.

Registry
clinicaltrials.gov
Start Date
November 1, 1999
End Date
October 13, 2030
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Establish a centralized repository for the collection and distribution ofsamples

Time Frame: Ongoing

Collection of biospecimens

Study Sites (1)

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