RECRUITING

Evaluation of Patients With HAM/TSP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally. Additionally, we will attempt to define the virological and immunological changes of HAM/TSP. Study Population: Patients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate. Design and Outcome Measures: A longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures may be performed on all participants. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response, and the genetic makeup.

Official Title

Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)

Quick Facts

Study Start:1998-04-06
Study Completion:N/A
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00001778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Test positive for HTLV infection (positive HTLV-1 ELISA followed by a positive Western blot)
  2. * Positive HTLV ELISA but a Western Blot that only partially fulfills the above criteria (seroindeterminate)
  3. * Have a family member/significant other who is HTLV positive, and may have been exposed to the virus
  4. * Healthy volunteer AND
  5. * Willingness to participate in the protocol evaluations and procedures.
  1. * Unwillingness or inability to participate in the protocol evaluations and procedures.
  2. * The presence of any medical, social, or psychiatric conditions that in the opinion of the investigator may affect the safety of the patients or compliance with the protocol.
  3. * Patients/healthy volunteers under the age of 18 are excluded.

Contacts and Locations

Study Contact

Daniel S Reich, M.D.
CONTACT
(301) 496-1801
reichds@ninds.nih.gov
Steven Jacobson, Ph.D.
CONTACT
(301) 496-0519
jacobsons@ninds.nih.gov

Principal Investigator

Steven Jacobson, Ph.D.
PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

  • Steven Jacobson, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute of Neurological Disorders and Stroke (NINDS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date1998-04-06
Study Completion DateN/A

Study Record Updates

Study Start Date1998-04-06
Study Completion DateN/A

Terms related to this study

Keywords Provided by Researchers

  • Immune Response
  • Sero-Indeterminant
  • Transmission
  • HTLV-1
  • HTLV-1 Associated Myelopathy
  • Natural History
  • HTLV-I
  • HAM/TSP

Additional Relevant MeSH Terms

  • HTLV-I Infection
  • Tropical Spastic Paraparesis