CompletedPhase 4

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

United States150 participantsStarted 2018-01-15

Plain-language summary

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All Specimens: * Male or female * Biorepository specimen de-identified of PHI * Specimen meets HTLV Blot 2.4 labeling collection/handling criteria HTLV Positive Specimens: Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II Neurological Disorders: Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders: * Acute Disseminated Encephalitis * Amyotrophic Lateral Sclerosis (ALS) * Autonomic Dysfunction * Conus Medularis Syndrome * Chronic Inflammatory Demyelinating Polyneuropathy * Dermatomyositis * HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP) * Meningitis * Mild Cognitive Impairment * Multiple Sclerosis (MS) * Polymyositis * Spastic Paraparesis * Sciatica Exclusion Criteria: HTLV Infected: * specimens with a known infection or history of HIV, HCV or HBV * specimens not meeting specimen labeling collection / handling criteria Neurological Disorders * specimens not meeting specimen labeling collection / handling criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens

Timeframe: 3 months

To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens

Timeframe: 3 months

Trial details

NCT IDNCT03226119

SponsorMP Biomedicals, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-10

View on ClinicalTrials.gov More HTLV-I Infections trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.