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Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System

NCT01694875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2012-11-14

No results posted yet for this study

Summary

The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening.

This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at increased risk of cervical disease in a sample population of women with negative (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.

Conditions

  • Human Papillomavirus Infection

Interventions

DEVICE

APTIMA HPV Assay

In Vitro Diagnostics Assay

Sponsors & Collaborators

  • Gen-Probe, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jennifer L Reid, PhD · Gen-Probe, Incorporated

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-11-30
Completion
2012-11-30

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 NCT01694875 on ClinicalTrials.gov