Understanding negative HPV test results with late amplification signals
Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ?
This study is trying to see if a new testing method can help better understand negative HPV test results in women and improve cervical cancer diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 47 (estimated) |
| Sex | Female |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest, Brittany) |
| Trial ID | NCT06919627 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the diagnosis of cervical cancer by analyzing cases where a negative HPV test result is accompanied by a late amplification signal using GeneXpert® technology. It will evaluate the presence of epithelial lesions through cytological controls in patients who have undergone cervico-uterine and anal smear samples at Brest University Hospital. The study will compare the GeneXpert® results with those from a conventional pan-genotypic Papillomavirus PCR test to improve interpretation of HPV testing outcomes.
Who should consider this trial
Good fit: Ideal candidates are women whose cervico-uterine swabs tested negative for HPV but showed a late amplification signal.
Not a fit: Patients with a positive HPV test or those without any amplification signal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy for cervical cancer, potentially reducing missed cases.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Brest, Brittany
- CHU de BREST — Brest, Brittany, France (Recruiting)
Study contacts
- Principal investigator: Christopher PAYAN, PU-PH — CHU de Brest
- Study coordinator: Christopher PAYAN
- Email: christopher.payan@chu-brest.fr
- Phone: 0298345099
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.