Evaluating HPV Integration for Detecting Cervical Precancer in HPV-positive Women
Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women：a Prospective Cohort Study
This study is testing if a new HPV integration test can better identify cervical precancer in women aged 20 to 70 who have already tested positive for HPV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2200 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | Female |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05570331 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of HPV integration testing as a triage method for cervical cancer screening in women who test positive for HPV. The research builds on previous findings that suggest HPV integration is highly specific for detecting cervical precancerous lesions. By conducting a large prospective cohort study, the team will evaluate the clinical performance of this novel triage strategy compared to traditional screening methods. The study focuses on women aged 20 to 70 who have received HPV-positive results and aims to improve the specificity of cervical cancer screening.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 to 70 who have tested positive for HPV.
Not a fit: Patients who have previously been diagnosed with cervical cancer or other malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce unnecessary colposcopies and overtreatment in HPV-positive women.
How similar studies have performed: Previous studies have shown promising results for HPV integration testing, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Wuhan, Hubei
- Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Ting Hu, MD, PhD
- Email: cat_huting@163.com
- Phone: 862783662681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.