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

Human Papillomavirus Infection Clinical Trial

— AHPV-GT  

Official title:

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the TIGRIS® DTS® 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: NCT01384370
• Other study ID #: HPVGTS-US10-002
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: October 4, 2011
• Start date: June 2011
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Gen-Probe, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT Assay) is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18 and 45 in cervical specimens from women with positive results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate between HPV 18-positive samples and HPV 45-positive samples. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination) may be tested with the AHPV-GT Assay either pre- or post-Pap processing. The assay is used with the TIGRIS DTS (TIGRIS) System.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1260
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • the subject attended a colposcopy visit, and

• the referral Pap sample had a valid APTIMA HPV Assay result, and

• the sample had an APTIMA HPV Assay positive result, or

• the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 [CIN2] or more severe (eg, CIN2, CIN grade 3 [CIN3], or cervical cancer; "CIN2+"), or

• the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid APTIMA HPV Assay result, and

• the sample had an APTIMA HPV Assay positive result, or

• the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or

• the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of <CIN2 and was randomly selected for inclusion.

Exclusion Criteria:

• Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
United States	Laboratory Corporation of America	Burlington	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	North Shore LIJ Health System Laboratories	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45	Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status	6 months	No
Primary	Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples	Specificity (%) = TN/(TN + FP) x100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status	6 months	No