Negative HPV Test Results on Infinity/GeneXpert® With the Presence of a Late Amplification Signal: What Does This Mean ? (PaPCR)

NCT06919627 | Completed

• 1 other identifier: 29BRC25.0053 - PaPCR
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancers; Papillomavirus Infections; Papillomavirus Type 16/18 Infection

Keywords

papillomavirus; cancer; virology; PCR; GeneXpert; cervical cancer

Outcome Measures

Primary Outcomes (6)

• Age

  in years

  3 years

• Date of sampling

  DD/MM/YYYY

  3 years

• Cytology of sample

  presence or absence of intraepithelial lesions

  3 years

• Clinical history

  history of intraepithelial lesions or previous HPV test

  10 years

• Conization of lesions

  yes or no

  3 years

• Treatment

  yes or no

  3 years

Study Arms (1)

PCR HPV test with a late amplification signal in GeneXpert® : negative

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

Eligibility Criteria

• Gender Eligibility Details: Women only (cervico-uterine sample tested)
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who had a PCR HPV test with a late amplification signal in GeneXpert® and were found to be negative.

You may qualify if:

• 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.

You may not qualify if:

• Patients with a positive cervico-uterine swab for Papillomavirus.
• Patients with a negative test with no amplification signal.
• Patients under legal protection (guardianship, curatorship, etc.).

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de BREST

Brest, Brittany Region, 29200, France

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher PAYAN, PU-PH

  CHU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: March 27, 2025
• Primary Completion: April 14, 2025
• Study Completion: January 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)