Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Papillomavirus Infections | — | UNRESOLVED | — |
| Papillomavirus Type 16/18 Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- PCR HPV test with a late amplification signal in GeneXpert® : negative
- description
- Patients whose cervico-uterine sample was initially negative on the GeneXpert® system, but who had a late Ct signal (\>35) on the initial gross result. Inclusion period: 01/01/2022 to 06/30/2024
Primary outcomes (6)
- measure
- Age
- timeFrame
- 3 years
- description
- in years
- measure
- Date of sampling
- timeFrame
- 3 years
- description
- DD/MM/YYYY
- measure
- Cytology of sample
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available