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

Human Papillomavirus Infection Clinical Trial

Official title:

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694875
• Other study ID #: HPVGPS-US12-001
• Status: Completed
• Phase: N/A
• First received: September 24, 2012
• Last updated: November 12, 2012
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Subjects who were previously enrolled into the prospective, multicenter US clinical study for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this protocol. All evaluable ASC-US Study subjects =21 years of age will be eligible for inclusion.

Evaluable Adjunct Study subjects =30 years of age will be eligible if the following criteria are met:

• the subject attended the colposcopy visit, or

• the subject did not attend the colposcopy visit but the referral Pap sample had a positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol AHPVPS-US11-003).

Exclusion Criteria:

Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Intervention

Device:
• APTIMA HPV Assay
In Vitro Diagnostics Assay

Locations

Country	Name	City	State
United States	Laboratory Corporation of America	Burlington	North Carolina
United States	Molecular Pathology Laboratory Network, Inc	Maryville	Tennessee
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States,