NCT03226119

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

July 19, 2017

Last Update Submit

September 12, 2018

Conditions

HTLV-I InfectionsHTLV-II InfectionsHuman T-lymphotropic Virus 1Human T-lymphotropic Virus 2HTLV I Associated T Cell Leukemia LymphomaHTLV I Associated Myelopathies

Keywords

HTLVConfirmatorySupplementalBlotHTLV-IHTLV-II

Outcome Measures

Primary Outcomes (2)

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

    3 months

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

    3 months

Study Arms (2)

HTLV Infected (n=50)

EXPERIMENTAL

Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)

Diagnostic Test: MP Diagnostics HTLV Blot 2.4

Neurological Disorders (n=100)

EXPERIMENTAL

Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica

Diagnostic Test: MP Diagnostics HTLV Blot 2.4

Interventions

MP Diagnostics HTLV Blot 2.4DIAGNOSTIC_TEST

HTLV I/II Confirmation and Differentiation

Also known as: HTLV I/II Western Blot Assay
HTLV Infected (n=50)Neurological Disorders (n=100)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

LABS, Inc.

Philadelphia, Pennsylvania, 19123, United States

Location

Qualtex Laboratories

San Antonio, Texas, 78201, United States

Location

Eastern Virginia Medical School (EVMS)

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

  • 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.

    PMID: 26589659BACKGROUND

MeSH Terms

Conditions

HTLV-I InfectionsHTLV-II InfectionsLeukemia-Lymphoma, Adult T-CellParaparesis, Tropical Spastic

Condition Hierarchy (Ancestors)

Deltaretrovirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsImmunologic Deficiency SyndromesImmune System DiseasesLeukemia, T-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersMyelitisCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Officials

  • Sara Dionne, PhD

    LABS, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Clinical Sites and the Reference Core-Lab will be masked of specimen disease state
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

January 15, 2018

Primary Completion

July 10, 2018

Study Completion

August 31, 2018

Last Updated

September 13, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

All clinical study data will be compiled and shared with investigators following database lock.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Q4 2017

Locations

US(3)