CompletedPhase 3

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

United States12,896 participantsStarted 2008-03

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adjunct Study Arm: Compare Assay Performance for Aptima HPV Assay to a FDA-Approved HPV Assay for Detecting CIN2+

Timeframe: Baseline Evaluation

Adjunct Study Arm: Compare Assay Performance for FDA-Approved HPV DNA Assay to a FDA-Approved HPV Assay for Detecting CIN2+

Timeframe: Baseline Evaluation

Trial details

NCT IDNCT00973362

SponsorGen-Probe, Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

Results submitted2016-07-28

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