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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


N/A
18 Years
N/A
Not Enrolling
Female
Human Papillomavirus Infection

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Trial Information

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


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.


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 ( 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 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).

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45

Outcome Description:

Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Tadd S Lazarus, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gen-Probe, Incorporated

Authority:

United States: Institutional Review Board

Study ID:

HPVGTS-US10-002

NCT ID:

NCT01384370

Start Date:

June 2011

Completion Date:

August 2011

Related Keywords:

  • Human Papillomavirus Infection
  • Warts
  • Papillomavirus Infections

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
North Shore LIJ Health System LaboratoriesLake Success, New York  11042
Laboratory Corporation of AmericaBurlington, North Carolina  27215