Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ?

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The aim of this retrospective, single-center, observational study is to improve the diagnosis and interpretation of cervical cancer by better detection of epithelial lesions in the case of a late HPV PCR amplification signal rendered negative by routine laboratory testing using GeneXpert® technology. The various evaluation criteria are : * Presence or absence of lesions on cytological control following a negative HPV test with a late amplification signal on cervico-uterine and anal smear samples from patients seen in consultation at Brest University Hospital from 01/01/2022 to 30/06/2024 (after conventional PCR and genotyping). * Comparison of the GeneXpert® technique with the results of another conventional pan-genotypic Papillomavirus PCR test.

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Patients whose cervico-uterine swab was initially rendered negative by the GeneXpert® system when a late Ct signal (\>35) was present in the raw result.

Locations
Other Locations
France
CHU de BREST
RECRUITING
Brest
Contact Information
Primary
Christopher PAYAN
christopher.payan@chu-brest.fr
0298345099
Backup
Valentin LEMOINE
valentinlemoine@orange.fr
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 47
Treatments
PCR HPV test with a late amplification signal in GeneXpert® : negative
Patients whose cervico-uterine sample was initially negative on the GeneXpert® system, but who had a late Ct signal (\>35) on the initial gross result.~Inclusion period: 01/01/2022 to 06/30/2024
Sponsors
Leads: University Hospital, Brest

This content was sourced from clinicaltrials.gov