Clinical Trials Logo
  1. Home
  2. Human Papilloma Virus Infection
  3. NCT01446198
  4. Details
NCT01446198 Clinical Trial

Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

Human Papilloma Virus Infection Clinical Trial

Official title:
Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

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

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04199078 - Clinical Trial to Explore Papilocare Gel Efficacy to Repair of the Cervico-vaginal Mucosa With HPV High Risk Lesions. N/A
Active, not recruiting NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions Phase 3
Active, not recruiting NCT02258659 - Nab-paclitaxel and Carboplatin Followed by Response-Based Local Therapy in Treating Patients With Stage III or IV HPV-Related Oropharyngeal Cancer Phase 2
Completed NCT02714114 - Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study) N/A
Completed NCT00303823 - Green Tea Extract in Preventing Cervical Cancer in Patients With Human Papillomavirus and Low-Grade Cervical Intraepithelial Neoplasia Phase 2
Not yet recruiting NCT05510830 - Diagnostic Cervical Conization for Persistent Infection or Integration of HPV N/A
Completed NCT04002154 - Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV N/A
Not yet recruiting NCT06123533 - Understanding Women's Values in Managing Human Papillomavirus (HPV)
Completed NCT04624568 - Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance N/A
Completed NCT05694728 - A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine Phase 2
Completed NCT04391647 - Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
Recruiting NCT05439083 - Immunogenicity of 9-valent HPV Vaccine Phase 4
Completed NCT01539668 - Hybrid Capture Test on Mobile Unit Program to Improve Cervical Cancer Screening in Brazilian Rural and Remote Areas Phase 0
Recruiting NCT06467942 - Effects of Chinese Medicine and Lactobacillus in Persistent HPV Infection N/A
Completed NCT01567813 - Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)
Completed NCT02811367 - The HPV Self-test as a Test of Cure in Madagascar N/A
Completed NCT02067507 - Increasing Human Papillomavirus Vaccine Uptake in Low-Income, Ethnic Minority Adolescents in Los Angeles County N/A
Recruiting NCT01387997 - e- Ab Sensor-based Real-time Detection of Oncogenic Human Papilloma Viruses N/A
Completed NCT02634190 - Clinical Evaluation of the APTIMA® HPV Assay and Comparison With the HR HC2® Test Using LBC ThinPrep® Specimens
Completed NCT00054041 - Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia Phase 2