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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01446198
Other study ID # AHPVPS-US11-003
Secondary ID
Status Completed
Phase N/A
First received October 3, 2011
Last updated June 29, 2012
Start date March 2012
Est. completion date May 2012

Study information

Verified date June 2012
Source Gen-Probe, Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.


Description:

The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System.

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.


Recruitment information / eligibility

Status Completed
Enrollment 11816
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)

- an aliquot is available and suitable for testing, and

- the sample was randomly selected for inclusion.

Exclusion Criteria:

- sample integrity was compromised (eg, stored under unacceptable conditions)

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Locations

Country Name City State
United States LabCorp Corporation of America Burlington North Carolina
United States Hennepin County Medical Center Minneapolis Minnesota
United States Gen-Probe Incorporated San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Gen-Probe, Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary HPV Assay result Agreement between TIGRIS and PANTHER Systems Percent Positive Agreement: The number of samples with a positive HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a positive HPV Assay result on TIGRIS, multiplied by 100
Percent Negative Agreement: The number of samples with a negative HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a negative HPV Assay result on TIGRIS, multiplied by 100
1 month No
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