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APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results

NCT01384370 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1260

Last updated 2011-10-06

No results posted yet for this study

Summary

In both the ASC-US Study and Adjunct Study populations, the objectives are to:

* evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and
* evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.

Conditions

  • Human Papillomavirus Infection

Sponsors & Collaborators

  • Gen-Probe, Incorporated

    lead INDUSTRY

Principal Investigators

  • Tadd S Lazarus, M.D. · Gen-Probe, Incorporated

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

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 NCT01384370 on ClinicalTrials.gov