← Back to Clinical Trials
Recruiting NCT06919627

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

Trial Parameters

Condition Cervical Cancers
Sponsor University Hospital, Brest
Study Type OBSERVATIONAL
Phase N/A
Enrollment 47
Sex FEMALE
Min Age N/A
Max Age N/A
Start Date 2025-03-01
Completion 2025-08-31

Brief 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 Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Patients with a positive cervico-uterine swab for Papillomavirus. * Patients with a negative test with no amplification signal. * Patients who have expressed opposition to inclusion in the study. * Patients under legal protection (guardianship, curatorship, etc.).

Related Trials