Clinical trial NCT03226119: MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study
Official title: HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HTLV-I Infections
HTLV-II Infections
Human T-lymphotropic Virus 1
Human T-lymphotropic Virus 2
HTLV I Associated T Cell Leukemia Lymphoma
HTLV I Associated Myelopathies
Keywords: HTLV
Confirmatory
Supplemental
Blot
HTLV-I
HTLV-II
Lead sponsor: MP Biomedicals, LLC
Sponsor class: INDUSTRY
Collaborators: name: MP Biomedicals Asia Pacific Pte. Ltd.
First posted: 2017-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens
Primary purpose: DIAGNOSTIC

Brief 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).

Detailed description: The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: LABS, Inc.
state: Pennsylvania
city: San Antonio
country: United States
facility: Qualtex Laboratories
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School (EVMS)
state: Virginia
Study officials:
affiliation: LABS, Inc.
name: Sara Dionne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11.