Know Cancer

or
forgot password

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens


N/A
21 Years
N/A
Not Enrolling
Female
Human Papillomavirus Infection

Thank you

Trial Information

Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens


Inclusion Criteria:



Subjects who were previously enrolled into the prospective, multicenter US clinical study
for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible
for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this
protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for
inclusion.

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).

Exclusion Criteria:

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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Principal Investigator

Jennifer L Reid, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Gen-Probe, Incorporated

Authority:

United States: Food and Drug Administration

Study ID:

HPVGPS-US12-001

NCT ID:

NCT01694875

Start Date:

October 2012

Completion Date:

November 2012

Related Keywords:

  • Human Papillomavirus Infection
  • cervix cancer
  • HPV
  • APTIMA
  • Warts
  • Papillomavirus Infections

Name

Location

Hennepin County Medical CenterMinneapolis, Minnesota  
Laboratory Corporation of AmericaBurlington, North Carolina  27215
Molecular Pathology Laboratory Network, IncMaryville, Tennessee  37804