NCT02092233

Brief Summary

The ARIES HSV 1\&2 Assay is a PCR based test for the direct detection and typing of herpes simplex virus (HSV 1 \& 2) DNA. The objective is to establish the diagnostic accuracy of ARIES HSV-1\&2 Assay.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1,963

participants targeted

Target at P75+ for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

March 17, 2014

Last Update Submit

July 9, 2015

Conditions

Herpes

Keywords

ARIES HSV 1&2

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

    Within the first year of sample collection

Study Arms (2)

Blinded, Prospective Arm

The diagnostic accuracy for lesions from individuals suspected of having a herpes infection will be evaluated in prospectively collected, left-over de-identified, clinical specimens accrued between pre-defined dates.

Blinded, Pre-selected Arm

For specimen types that are less common, banked, pre-selected, positive clinical specimens will be tested.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Clinical lesions from pediatic or adult patients suspected of having herpes infection

You may qualify if:

  • The specimen is from one of the following lesion sources: male internal and external anogenital, female internal anogenital, female external anogenital, oral or skin The specimen is collected and maintained in unexpired Copan universal transport medium

You may not qualify if:

  • The specimen was not properly collected, transported or stored according to instructions provided by Sponsor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Tricore

Albuquerque, New Mexico, 87102, United States

Location

Labcorp

Burlington, North Carolina, 27215, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patient lesion swab specimens

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Himsworth

    Luminex Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Last Updated

July 10, 2015

Record last verified: 2014-03

Locations

US(3)