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
Trial Information
Current as of July 23, 2025
Recruiting
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.).
About University Hospital, Brest
The University Hospital of Brest is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. With a strong emphasis on interdisciplinary collaboration, the hospital serves as a hub for cutting-edge clinical trials aimed at improving treatment outcomes across various medical specialties. Leveraging its robust academic affiliations and state-of-the-art facilities, the University Hospital of Brest is committed to fostering scientific discovery and enhancing the quality of life for patients through evidence-based practices and pioneering research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brest, Brittany, France
Patients applied
Trial Officials
Christopher PAYAN, PU-PH
Principal Investigator
CHU de Brest
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported