Clinical trial NCT01384370: APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infection
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 1260
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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)

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.

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 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).

Primary outcomes:
measure: Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45
timeFrame: 6 months
measure: Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: North Shore LIJ Health System Laboratories
state: New York
city: Burlington
country: United States
facility: Laboratory Corporation of America
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Gen-Probe, Incorporated
name: Tadd S Lazarus, M.D.
role: STUDY_DIRECTOR
References: