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Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01446198
First received: October 3, 2011
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.


Condition
Human Papilloma Virus Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

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

Primary Outcome Measures:
  • HPV Assay result Agreement between TIGRIS and PANTHER Systems [ Time Frame: 1 month ] [ Designated as safety issue: No ]

    Percent Positive Agreement: The number of samples with a positive HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a positive HPV Assay result on TIGRIS, multiplied by 100

    Percent Negative Agreement: The number of samples with a negative HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a negative HPV Assay result on TIGRIS, multiplied by 100



Biospecimen Retention:   Samples With DNA

Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, In., Marlborough, MA) with commercially available collection device or cytobrush/spatula combination may be tested with the HPV Assay either pre- or post-Pap processing.


Enrollment: 11816
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
AHPV positive and negative subjects

Detailed Description:

The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System.

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects with AHPV Assay positive results and subjects with AHPV negative results

Criteria

Inclusion Criteria:

  • the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)
  • an aliquot is available and suitable for testing, and
  • the sample was randomly selected for inclusion.

Exclusion Criteria:

  • sample integrity was compromised (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: NCT01446198

Locations
United States, California
Gen-Probe Incorporated
San Diego, California, United States, 92121
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, North Carolina
LabCorp Corporation of America
Burlington, North Carolina, United States, 27215
Sponsors and Collaborators
Gen-Probe, Incorporated
Investigators
Study Director: Tadd S Lazarus, M.D. Gen-Probe, Incorporated
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01446198     History of Changes
Other Study ID Numbers: AHPVPS-US11-003
Study First Received: October 3, 2011
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Gen-Probe, Incorporated:
HPV

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

ClinicalTrials.gov processed this record on November 19, 2014