Clinical Trial

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

Study acronym: PaPCR
Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-02.
Status change: Recruiting → Completed 2026-04-01
Trial Details
NCT Number NCT06919627
Lead Sponsor University Hospital, Brest
Conditions Cervical Cancers, Papillomavirus Infections, Papillomavirus Type 16/18 Infection
Enrollment 45 participants
Start Date 2025-03-27
Primary Completion 2025-04-14 (estimated)
Study Completion 2026-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-02