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

Launched by UNIVERSITY HOSPITAL, BREST · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial, called PaPCR, is looking at how we can better diagnose cervical cancer in women. It focuses on cases where a test for the human papillomavirus (HPV) comes back negative, but there are signs that suggest the presence of the virus, specifically a late amplification signal. The study aims to understand if this late signal means there might still be changes in the cells that could lead to cancer, even when the initial test is negative. Researchers will be comparing the results from the GeneXpert® testing method with those from another HPV test to see how accurate they are in identifying potential problems.

To take part in this study, participants need to be women who had a negative HPV test result using the GeneXpert® system, but with a late signal indicating possible issues. Women who have a positive HPV test or those who don't show any signals at all will not be included. Participants will have their samples reviewed to see if any cell changes are present, and this will help improve how doctors diagnose and manage cervical cancer. It's important to note that the study is currently recruiting participants and will take place at Brest University Hospital over the next couple of years.

Gender

FEMALE

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.).