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

Completed

Conditions studied: Human Papillomavirus Infection

In brief

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.

Key facts

Study ID

NCT01384370

Run by

Gen-Probe, Incorporated

People needed

1260

Starts

2011-06-01

Expected to finish

2011-08-01

Last updated by the study team

2011-10-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• • 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.

You may not qualify if…

• 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).

Where it is running

• North Shore LIJ Health System Laboratories — Lake Success, New York, United States
• Laboratory Corporation of America — Burlington, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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