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

NCT06919627 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Cervical Cancers
  • Papillomavirus Infections
  • Papillomavirus Type 16/18 Infection

Sponsors & Collaborators

  • University Hospital, Brest

    lead OTHER

Principal Investigators

  • Christopher PAYAN, PU-PH · CHU de Brest

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2025-04-14
Completion
2026-01-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06919627 on ClinicalTrials.gov