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
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.
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.
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.
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|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||838 participants|
|Official Title:||Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick|
|Study Start Date :||October 19, 1999|
- Establish a centralized repository for the collection and distribution ofsamples [ Time Frame: Ongoing ]
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
|United States, Maryland|
|NCI Frederick Cancer Research Center|
|Frederick, Maryland, United States, 21702-1201|
|Principal Investigator:||Janelle Cortner, Ph.D.||National Cancer Institute (NCI)|