HTLV-1 Carriers and HTLV-1 Associated Illnesses in Blood Donors in Jamaica

This study is ongoing, but not recruiting participants.

First Received: October 13, 2007 Last Updated: February 6, 2009 History of Changes

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00544661

Purpose

RATIONALE: Collecting information about HTLV-1 carriers and HTLV-1 associated illnesses in blood donors in Jamaica may help doctors learn more about these diseases.

PURPOSE: This clinical trial is studying HTLV-1 carriers and HTLV-1 associated illnesses in blood donors in Jamaica.

Condition	Intervention
Health Status Unknown	Genetic: molecular genetic technique Other: biologic sample preservation procedure Other: laboratory biomarker analysis Other: questionnaire administration Procedure: evaluation of cancer risk factors

MedlinePlus related topics: Blood Transfusion and Donation Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Natural History of HTLV-I: A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Comprehensive analysis of host genetic background of HTLV-I associated illnesses

Estimated Enrollment:	1500
Study Start Date:	May 2001
Estimated Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Provide a basis for a comparative study of HTLV-I carriers in Jamaica and a comprehensive analysis of host genetic background of HTLV-I associated illnesses in the Black population.

OUTLINE: Study participants undergo blood and urine sample collection to measure immune response and test for possible infection. Genetic tests are performed for HLA type antigens, cytokines, and other genes. Participants also complete a questionnaire and undergo phlebotomy and physical examination.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Human T-lymphotrophic virus type I (HTLV-I) positive or negative

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544661

Locations

Jamaica
University of the West Indies
Kingston, Jamaica, 7

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

James J. Goedert, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000564521, NCI-02-C-N112
Study First Received:	October 13, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00544661 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

health status unknown

Study placed in the following topic categories:

HTLV-I Infections

ClinicalTrials.gov processed this record on May 06, 2009