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Validation of BD Onclarity™ HPV Assay With PreservCyt® -ASCUS Samples

NCT03020121 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-01-31

No results posted yet for this study

Summary

The purpose of the study is to compare the results of the Becton Dickinson (BD) Human Papilloma Virus (HPV) Assay on the Viper LT instrument from Liquid-based cytology media diluted in HPV diluent to adjudicated histology results from biopsy.

Conditions

  • Uterine Cervical Neoplasm

Interventions

PROCEDURE

Colposcopy/biopsy

Colposcopy/biopsy will be performed on all subjects

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020121 on ClinicalTrials.gov