NCT06919627Completed
Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ? (PaPCR)
Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ?
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 45 (actual)
- First submitted
- 2 Apr 2025
- Start date
- 27 Mar 2025
- Primary completion date
- 14 Apr 2025
- Lead sponsor
- University Hospital, Brest
- Diseases
- Cervical cancer, Childhood cancers
- NCT number
- NCT06919627
What you commit to
- Study type: Observational
- Participants enrolled: 45
- From 27 Mar 2025 to the primary completion date, 14 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.).
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.