Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System

Gen-Probe

Status and phase: Completed; Phase 3

Conditions: Human Papillomavirus Infection

Treatments: Device: APTIMA HPV Assay; Device: FDA-Approved HPV DNA Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT00973362

2007HPVASCUS30

Details and patient eligibility

About

The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.

Full description

The primary objective of the clinical trial is to evaluate the APTIMA HPV Assay, using the TIGRIS System, in cervical cancer screening programs. This will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (HPV) types in women with known cervical disease status. The assay will be evaluated in sample populations of women with ASC-US Pap test results ("ASC-US results") and women 30 years of age or older ("30+ years of age") with negative (NILM) cytology results.

Enrollment: 12,896 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female 21 years or older (ASC-US study only)
• Female 30 years or older (Adjunct and ASC-US studies)
• Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
• Ability to comprehend and sign an IRB-approved Informed Consent Form

Exclusion criteria

• Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
• Abnormal Pap test result in the past 12 months
• Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
• Known to be pregnant
• Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
• Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
• Prior vaccination for HPV

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12,896 participants in 2 patient groups

Adjunct (i.e. Normal Pap)

Other group

Description:

The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period. A comparator FDA-Approved HPV DNA test is reported.

Treatment:

Device: FDA-Approved HPV DNA Test

Device: APTIMA HPV Assay

ASC-US

Other group

Description:

The ASC-US study will evaluate the APTIMA HPV Assay clinical performance for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results). A comparator FDA-Approved HPV DNA test is reported. There is no follow-up period.

Treatment:

Device: FDA-Approved HPV DNA Test

Device: APTIMA HPV Assay