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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01694875
First received: September 24, 2012
Last updated: November 12, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Human Papillomavirus Infection
Device: APTIMA HPV Assay

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Further study details as provided by Gen-Probe, Incorporated:

Estimated Enrollment: 2200
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No Treatment Device: APTIMA HPV Assay
In Vitro Diagnostics Assay

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Samples from subjects who attended colposcopy from the Adjunct Study and subjects who had positive APTIMA HPV Assay results in the APTIMA HPV Assay TIGRIS System Study or the APTIMA HPV Assay PANTHER System Study.

Criteria

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694875

Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, North Carolina
Laboratory Corporation of America
Burlington, North Carolina, United States, 27215
United States, Tennessee
Molecular Pathology Laboratory Network, Inc
Maryville, Tennessee, United States, 37804
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Jennifer L Reid, PhD Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01694875     History of Changes
Other Study ID Numbers: HPVGPS-US12-001
Study First Received: September 24, 2012
Last Updated: November 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gen-Probe, Incorporated:
cervix cancer
HPV
APTIMA

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014