CompletedNot Applicable

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

United States1,260 participantsStarted 2011-06

Plain-language 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.

Who can participate

Age range

18 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: * • 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).

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

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

Timeframe: 6 months

Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples

Timeframe: 6 months

Trial details

NCT IDNCT01384370

SponsorGen-Probe, Incorporated

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2011-08

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