Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women

Recruiting

• Conditions: HPV Infection; Cervical Cancer

• Registration Number: NCT05570331
• Lead Sponsor: Ding Ma

Brief Summary

The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Detailed Description

Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P \< 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Primary Completion: 2023-02-28
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2200

Inclusion Criteria

• Consenting women aged 20y-70y with HPV-positive results

Exclusion Criteria

• Not providing informed consent
• previously confirmed CIN, cervical cancer, or other malignancies
• previous therapeutic procedure to cervix
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of CIN3+ disease	3 years	CIN3+ diagnosed on biopsy obtained at colposcopy.
Risk of CIN2+ disease	3 years	CIN2+ diagnosed on biopsy obtained at colposcopy.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China