Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System

NCT01694875 | Completed

• 1 other identifier: HPVGPS-US12-001
• Study Type: observational
• Target: 2,200
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening. This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at increased risk of cervical disease in a sample population of women with negative (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.

Conditions

Human Papillomavirus Infection

Keywords

cervix cancer; HPV; APTIMA

Study Arms (1)

No Treatment

Device: APTIMA HPV Assay

Interventions

APTIMA HPV Assay DEVICE

In Vitro Diagnostics Assay

No Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Samples from subjects who attended colposcopy from the Adjunct Study and subjects who had positive APTIMA HPV Assay results in the APTIMA HPV Assay TIGRIS System Study or the APTIMA HPV Assay PANTHER System Study.

You may qualify if:

• Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following criteria are met:
• the subject attended the colposcopy visit, or
• the subject did not attend the colposcopy visit but the referral Pap sample had a positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol AHPVPS-US11-003).

You may not qualify if:

• Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

Sponsors & Collaborators

• Gen-Probe, Incorporated: lead

Study Sites (3)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Laboratory Corporation of America

Burlington, North Carolina, 27215, United States

Location

Molecular Pathology Laboratory Network, Inc

Maryville, Tennessee, 37804, United States

Location

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Jennifer L Reid, PhD

  Gen-Probe, Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

US (3)