HTLV-INCT00339807
Natural History of HTLV-I Infection: Prospective Follow-up of a Cohort of Blood Donors in Jamaica
An observational study of HTLV-I, run by National Cancer Institute (NCI) at 1 site in Jamaica.
Trial summary
Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean, but disease manifestations differ across geographic regions. Though age, gender, and route of infection may determine the natural history of this infection, the observed geographic differences also may, in part, reflect the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HTLV-I
- How many people
- 1,500 participants
- Where
- 1 siteJamaica
- Study dates
- 17 Jan 2002to 11 Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy blood donors in Kingston, Jamaica.
- All HTLV-I positive donors and age-, sex-matched HTLV-1 negative donors (controls) will be enrolled.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Natural History of HTVL-I: A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica
Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean, but disease manifestations differ across geographic regions. Though age, gender, and route of infection may determine the natural history of this infection, the observed geographic differences also may, in part, reflect the distinct genetic background of the host as evidenced by the distribution of human leukocyte antigens (HLA) and the presence of other environmental factors.
Studies already completed or ongoing have shown notable differences in incidence and prevalence of HTLV-I associated diseases and underscore the need for comparative studies and analyses in these areas. This prospective new study of blood donors in Jamaica provides us with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan.
Read more
This study will
- identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis.
- directly calculate the incidence of HTLV-I associated diseases in this population.
- examine the role of HTLV-I in the pathogenesis of other common infectious agents.
Approximately 5,000+ blood donors who came to the National Blood Transfusion each year will be screened for HTLV-I serology. Of those who agreed to participate, all HTLV-I carriers and age-, and sex-matched HTLV-I-negatives will be invited to the University of the West Indies clinic for a full study enrollment. Study participants will be given a standardized questionnaire, a full physical examination, and a phlebotomy (25-30 mL), and will be followed every other year for interim health status and additional phlebotomy. All subjects will receive an ophthalmologic examination for detection of uveitis and other ocular diseases. Some subjects will be further referred to a neurologist, hematologist or dermatologist, according to their signs and symptoms. Approximately 1200 HTLV-I carriers and 600 HTLV-I negatives will be recruited for a longitudinal follow-up over the next 5-year period. Two types of analyses will be conducted: comparison of HTLV-I-positive and HTLV-I-negative subjects, and comparison among HTLV carriers between those with a high level of viral load and those with a low level.
Read the detailed description
Southern Japan and the Caribbean are both endemic for human T-lymphotropic virus type I (HTLV-I) infection. In these areas, however, epidemiology of HTLV-I appears to differ. Various observations from population-based studies indicate that differences in host immune response to virus infection is likely to result in different frequencies of disease manifestations across geographic regions. While gender, age and route of infection may partly determine host immune response, the observed geographic differences may also reflect, in part, host genetic background as evidenced by the distribution of human leukocyte antigens (HLA) and presence of other environmental factors.
The reported differences underscore the need for comparative studies in these endemic areas. In addition, analyses of larger, pooled data of HTLV-I carriers from different geographic areas are needed to ensure statistical power in studies of gene-environment interactions with extended use of molecular markers. However, existing population-based studies from Japan and the Caribbean are unfortunately no comparable with respect to the study subject's age and gender distributions. In order to address this issue, we proposed a study of blood donors in Jamaica, which enrolls a large number of both HTLV-I positive and HTLV-I negative, consisting of subjects that are more comparable to existing Japanese study with respect to age and sex. The proposed study will provide a basis for a comparative study of HTLV-I carriers in Japan and Jamaica and a comprehensive analysis of host genetic background of HTLV-I associated illnesses in the Black population.
- Conditions
- HTLV-I
- Keywords
- Retrovirus, Caribbean, Transmission, Genetic, Viral Markers, HTLV-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start17 Jan 2002
- Study completion11 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HTLV-IStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339807
- Sponsor's protocol ID
- 999902112
- Other IDs
- 02-C-N112
- Status last verified
- 11 Aug 2011
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Poiesz BJ, Ruscetti FW, Gazdar AF, Bunn PA, Minna JD, Gallo RC. Detection and isolation of type C retrovirus particles from fresh and cultured lymphocytes of a patient with cutaneous T-cell lymphoma. Proc Natl Acad Sci U S A. 1980 Dec;77(12):7415-9. doi: 10.1073/pnas.77.12.7415.
PubMed 6261256Hinuma Y, Nagata K, Hanaoka M, Nakai M, Matsumoto T, Kinoshita KI, Shirakawa S, Miyoshi I. Adult T-cell leukemia: antigen in an ATL cell line and detection of antibodies to the antigen in human sera. Proc Natl Acad Sci U S A. 1981 Oct;78(10):6476-80. doi: 10.1073/pnas.78.10.6476.
PubMed 7031654Madeleine MM, Wiktor SZ, Goedert JJ, Manns A, Levine PH, Biggar RJ, Blattner WA. HTLV-I and HTLV-II world-wide distribution: reanalysis of 4,832 immunoblot results. Int J Cancer. 1993 May 8;54(2):255-60. doi: 10.1002/ijc.2910540216.
PubMed 8486428
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of HTVL-I: A Cross-Sectional Study of a Cohort of Blood Donors in Jamaica
- ClinicalTrials.gov ID
- NCT00339807
- Acronym / sponsor ID
- 999902112
- Conditions
- HTLV-I
- Keywords
- Retrovirus, Caribbean, Transmission, Genetic, Viral Markers, HTLV-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Jan 2002
- Study completion
- 11 Aug 2011
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Human T-lymphotrophic virus type I (HTLV-I) is endemic in southern Japan and the Caribbean, but disease manifestations differ across geographic regions. Though age, gender, and route of infection may determine the natural history of this infection, the observed geographic differences also may, in part, reflect the distinct genetic background of the host as evidenced by the distribution of human leukocyte antigens (HLA) and the presence of other environmental factors.
Studies already completed or ongoing have shown notable differences in incidence and prevalence of HTLV-I associated diseases and underscore the need for comparative studies and analyses in these areas. This prospective new study of blood donors in Jamaica provides us with an opportunity to address many hypotheses regarding HTLV-I transmission and pathogenesis in the Caribbean in comparison with an ongoing cohort study of HTLV-I carriers in Japan.
This study will
- identify host factors associated with HTLV-I carrier status and HTLV-I pathogenesis.
- directly calculate the incidence of HTLV-I associated diseases in this population.
- examine the role of HTLV-I in the pathogenesis of other common infectious agents.
Approximately 5,000+ blood donors who came to the National Blood Transfusion each year will be screened for HTLV-I serology. Of those who agreed to participate, all HTLV-I carriers and age-, and sex-matched HTLV-I-negatives will be invited to the University of the West Indies clinic for a full study enrollment. Study participants will be given a standardized questionnaire, a full physical examination, and a phlebotomy (25-30 mL), and will be followed every other year for interim health status and additional phlebotomy. All subjects will receive an ophthalmologic examination for detection of uveitis and other ocular diseases. Some subjects will be further referred to a neurologist, hematologist or dermatologist, according to their signs and symptoms. Approximately 1200 HTLV-I carriers and 600 HTLV-I negatives will be recruited for a longitudinal follow-up over the next 5-year period. Two types of analyses will be conducted: comparison of HTLV-I-positive and HTLV-I-negative subjects, and comparison among HTLV carriers between those with a high level of viral load and those with a low level.
Detailed description
Southern Japan and the Caribbean are both endemic for human T-lymphotropic virus type I (HTLV-I) infection. In these areas, however, epidemiology of HTLV-I appears to differ. Various observations from population-based studies indicate that differences in host immune response to virus infection is likely to result in different frequencies of disease manifestations across geographic regions. While gender, age and route of infection may partly determine host immune response, the observed geographic differences may also reflect, in part, host genetic background as evidenced by the distribution of human leukocyte antigens (HLA) and presence of other environmental factors.
The reported differences underscore the need for comparative studies in these endemic areas. In addition, analyses of larger, pooled data of HTLV-I carriers from different geographic areas are needed to ensure statistical power in studies of gene-environment interactions with extended use of molecular markers. However, existing population-based studies from Japan and the Caribbean are unfortunately no comparable with respect to the study subject's age and gender distributions. In order to address this issue, we proposed a study of blood donors in Jamaica, which enrolls a large number of both HTLV-I positive and HTLV-I negative, consisting of subjects that are more comparable to existing Japanese study with respect to age and sex. The proposed study will provide a basis for a comparative study of HTLV-I carriers in Japan and Jamaica and a comprehensive analysis of host genetic background of HTLV-I associated illnesses in the Black population.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy blood donors in Kingston, Jamaica.
- All HTLV-I positive donors and age-, sex-matched HTLV-1 negative donors (controls) will be enrolled.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 6261256Poiesz BJ, Ruscetti FW, Gazdar AF, Bunn PA, Minna JD, Gallo RC. Detection and isolation of type C retrovirus particles from fresh and cultured lymphocytes of a patient with cutaneous T-cell lymphoma. Proc Natl Acad Sci U S A. 1980 Dec;77(12):7415-9. doi: 10.1073/pnas.77.12.7415.
- Background: PubMed 7031654Hinuma Y, Nagata K, Hanaoka M, Nakai M, Matsumoto T, Kinoshita KI, Shirakawa S, Miyoshi I. Adult T-cell leukemia: antigen in an ATL cell line and detection of antibodies to the antigen in human sera. Proc Natl Acad Sci U S A. 1981 Oct;78(10):6476-80. doi: 10.1073/pnas.78.10.6476.
- Background: PubMed 8486428Madeleine MM, Wiktor SZ, Goedert JJ, Manns A, Levine PH, Biggar RJ, Blattner WA. HTLV-I and HTLV-II world-wide distribution: reanalysis of 4,832 immunoblot results. Int J Cancer. 1993 May 8;54(2):255-60. doi: 10.1002/ijc.2910540216.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HTLV-I, run by National Cancer Institute (NCI) at 1 site in Jamaica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339807, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.