RecruitingNCT06919627

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 ?


Sponsor

University Hospital, Brest

Enrollment

47 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is examining what it means when a cervical HPV (human papillomavirus) test shows a faint or late signal — technically a "negative" result, but with some hint of activity. Researchers want to find out if these borderline results are truly negative or might indicate a real HPV infection. **You may be eligible if...** - Your cervical swab was reported as negative by the GeneXpert system, but a faint late signal (Ct value greater than 35) was detected in the raw data **You may NOT be eligible if...** - Your HPV test came back positive - Your HPV test was negative with absolutely no signal at all - You are under legal protection such as guardianship - You objected to being included in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

CHU de BREST

Brest, Brittany Region, France

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NCT06919627


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