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

Cervical Cancer Clinical Trial

Official title:

Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women：a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570331
• Other study ID #: TJ-IRB20220142
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Tongji Hospital
• Contact: Ting Hu, MD, PhD
• Phone: 862783662681
• Email: cat_huting[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: December 31, 2025
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• HPV Infection
• Papillomavirus Infections
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Diagnostic Test:
• HPV integration test
HPV-positive patients who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Ding Ma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of CIN2+ disease	CIN2+ diagnosed on biopsy obtained at colposcopy.	3 years
Primary	Risk of CIN3+ disease	CIN3+ diagnosed on biopsy obtained at colposcopy.	3 years