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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 70
Healthy Volunteers: f
View:

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

Locations
Other Locations
China
Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Ting Hu, MD, PhD
cat_huting@163.com
862783662681
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 2200
Sponsors
Leads: Ding Ma

This content was sourced from clinicaltrials.gov