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

Sponsor

Gen-Probe, Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT01384370

Collaborator

(none)

1,260

Enrollment

Locations

Duration (Months)

420

Patients Per Site

209.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Human Papillomavirus Infection

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1260 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
AHPV positive and negative subjects

Outcome Measures

Primary Outcome Measures

Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45 [6 months]
Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status <CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status <CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay
Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples [6 months]
Specificity (%) = TN/(TN + FP) x100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status <CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status <CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Shore LIJ Health System Laboratories	Lake Success	New York	United States	11042
2	Laboratory Corporation of America	Burlington	North Carolina	United States	27215
3	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

Gen-Probe, Incorporated

Investigators

Study Director: Tadd S Lazarus, M.D., Gen-Probe, Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gen-Probe, Incorporated

ClinicalTrials.gov Identifier:

NCT01384370

Other Study ID Numbers:

HPVGTS-US10-002

First Posted:

Jun 29, 2011

Last Update Posted:

Oct 6, 2011

Last Verified:

Oct 1, 2011

Additional relevant MeSH terms:

Papillomavirus Infections

Study Results

No Results Posted as of Oct 6, 2011