NCT00340821

Brief Summary

Doctors of the University of West Indies, the Caribbean Epidemiology Center (CAREC) and the National Cancer Institute have been studying the epidemiology of HTLV-I and its role in the etiology and pathogenesis of adult T-cell leukemia/lymphoma (ALT), and aggressive T-cell lymphoma. The purpose of the current study is to evaluate familial and genetic aspects of ATL and its relationship to two other HTLV-I related conditions, HTLV-I associated myelopathy also known as tropical spastic paraparesis (HAM/TSP), and infective dermatitis. Enrollment of infective dermatitis cases was recently added and the disease entity is thought to be a harbinger for later development of either ATL or HAM/TSP. The purpose of this study is to interview patients with these conditions and perform laboratory studies (specifically, HLA and other viral or genetic studies) to better understand these diseases and their relationship to the HTLV-1 virus and the family history and genetic factors that may be involved as well.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1993

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 1993

Completed
13.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 2, 2017

Status Verified

March 1, 2011

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

HTLV-I

Keywords

HTLV-I

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All cases of ATL and TSP which satisfy the case definitions above. Cases will be selected regardless of HTLV-1 sero-status.

You may not qualify if:

  • Cases who have none of the first three priority family members available i.e. parents, offspring and siblings, will be excluded from this study however summary data will be maintained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of the West Indies

Kingston, Jamaica

Location

Related Publications (3)

  • Rodgers-Johnson P, Gajdusek DC, Morgan OS, Zaninovic V, Sarin PS, Graham DS. HTLV-I and HTLV-III antibodies and tropical spastic paraparesis. Lancet. 1985 Nov 30;2(8466):1247-8. doi: 10.1016/s0140-6736(85)90778-0. No abstract available.

    PMID: 2866324BACKGROUND

  • Murphy EL, Hanchard B, Figueroa JP, Gibbs WN, Lofters WS, Campbell M, Goedert JJ, Blattner WA. Modelling the risk of adult T-cell leukemia/lymphoma in persons infected with human T-lymphotropic virus type I. Int J Cancer. 1989 Feb 15;43(2):250-3. doi: 10.1002/ijc.2910430214.

    PMID: 2917802BACKGROUND

  • Kajiyama W, Kashiwagi S, Ikematsu H, Hayashi J, Nomura H, Okochi K. Intrafamilial transmission of adult T cell leukemia virus. J Infect Dis. 1986 Nov;154(5):851-7. doi: 10.1093/infdis/154.5.851.

    PMID: 2877031BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

May 17, 1993

Study Completion

March 1, 2011

Last Updated

July 2, 2017

Record last verified: 2011-03-01

Locations

JA(1)