Clinical trial · Observational
Evaluation of Patients With HAM/TSP
Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HTLV-I Infection | — | UNRESOLVED | — |
| Tropical Spastic Paraparesis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- healthy volunteers
- description
- At least 18 years old and have no history of any medical illness that may confound study results or make participation in this protocol impossible
- label
- individuals seropositive for HTLV
- description
- Positive HTLV-1 ELISA followed by a positive Western Blot
- label
- individuals with indeterminate HTLV sero-status
- description
- Positive HTLV ELISA but a Western Blot that only partially fulfills criteria
Primary outcomes (1)
- measure
- To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.
- timeFrame
- each study visit
- description
- To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
* INCLUSION CRITERIA: Participants that meet one of the following criteria: * Test positive for HTLV infection (positive HTLV-1 ELISA followed by a positive Western blot) * Positive HTLV ELISA but a Western Blot that only partially fulfills the above criteria (seroindeterminate) * Have a family member/significant other who is HTLV positive, and may have been exposed to the virus * Healthy volunteer AND * Willingness to participate in the protocol evaluations and procedures. EXCLUSION CRITERIA: * Unwillingness or inability to participate in the protocol evaluations and procedures. * 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. * Patients/healthy volunteers under the age of 18 are excluded.
References
Publications (3)
- BACKGROUNDGessain A, Barin F, Vernant JC, Gout O, Maurs L, Calender A, de The G. Antibodies to human T-lymphotropic virus type-I in patients with tropical spastic paraparesis. Lancet. 1985 Aug 24;2(8452):407-10. doi: 10.1016/s0140-6736(85)92734-5. PMID 2863442
- BACKGROUNDOsame M, Matsumoto M, Usuku K, Izumo S, Ijichi N, Amitani H, Tara M, Igata A. Chronic progressive myelopathy associated with elevated antibodies to human T-lymphotropic virus type I and adult T-cell leukemialike cells. Ann Neurol. 1987 Feb;21(2):117-22. doi: 10.1002/ana.410210203. PMID 2881513
- BACKGROUNDIwasaki Y. Pathology of chronic myelopathy associated with HTLV-I infection (HAM/TSP). J Neurol Sci. 1990 Apr;96(1):103-23. doi: 10.1016/0022-510x(90)90060-z. PMID 2351985