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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01384370
First received: February 18, 2011
Last updated: October 4, 2011
Last verified: October 2011
History of Changes
  Purpose

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
Human Papillomavirus Infection

Study Type: Observational
Study Design: 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

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

Primary Outcome Measures:
  • Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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



Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 1260
Study Start Date: June 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
AHPV positive and negative subjects

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.
  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

AHPV Assay positive results (~310 from subjects with a consensus histology result of <CIN2 or indeterminate disease status and 70 from subjects with CIN2+)

  • 150 randomly selected AHPV Assay negative samples from subjects with a consensus histology result of <CIN2 and All AHPV Assay negative samples from subjects with CIN2+ (~13 samples)
  • 300 from subjects with a consensus histology result of <CIN2 or indeterminate disease status, 15 from subjects with CIN2+, and 200 from subjects who did not attend the colposcopy visit) Approximately 150 randomly selected APTIMA HPV Assay negative samples from subjects with a consensus histology result of <CIN2 All APTIMA HPV Assay negative samples from subjects with CIN2+ (approximately 5 samples)
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384370

Locations
United States, New York
North Shore LIJ Health System Laboratories
Lake Success, New York, United States, 11042
United States, North Carolina
Laboratory Corporation of America
Burlington, North Carolina, United States, 27215
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Gen-Probe, Incorporated
ClinicalTrials.gov Identifier: NCT01384370     History of Changes
Other Study ID Numbers: HPVGTS-US10-002
Study First Received: February 18, 2011
Last Updated: October 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
 Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013