Understanding HPV Integration in Women with High-Grade Lesions
Prognostic Study of Different HPV Virus Integration in Women With HSIL
This study is trying to see how the HPV virus affects the health of women with high-grade lesions by looking at their cervical cells and vaginal health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | Female |
| Sponsor | Fujian Maternity and Child Health Hospital Academic / other |
| Locations | 13 sites (Fuzhou, Fujian and 12 other locations) |
| Trial ID | NCT05745597 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between HPV virus integration and disease outcomes in women diagnosed with high-grade squamous intraepithelial lesions (HSIL). A total of 1000 women will be recruited from multiple centers, with samples of cervical cells and vaginal secretions collected at various intervals to assess HPV integration status and vaginal flora diversity. The study will evaluate how these factors influence the progression of HSIL and the potential prognostic value of different HPV integration statuses.
Who should consider this trial
Good fit: Ideal candidates for this study are women with pathologically confirmed HSIL who have not undergone surgical treatment.
Not a fit: Patients who are pregnant, have a history of genital tract cancer, or have received recent treatment for genital infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the prognostic factors for women with HSIL, potentially leading to improved management and treatment strategies.
How similar studies have performed: While there have been studies on HPV and its implications in cervical cancer, this specific focus on HPV integration and its correlation with HSIL outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed HSIL(CIN2, 3) in women or cervical carcinoma in situ or early invasive cancer; * No surgical treatment or conization only; * Obtain informed consent. Exclusion Criteria: * During pregnancy or lactation; * Patients with a history of genital tract cancer; * Previous history of hysterectomy, cervical surgery or pelvic radiotherapy; * Received treatment related to genital tract infection, HPV or other STDs pathogen infection in the past one month; * Use of antibiotics or vaginal microecological improvement products in the past 1 month.
Where this trial is running
Fuzhou, Fujian and 12 other locations
- Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (Recruiting)
- Longyan First Hospital — Longyan, Fujian, China (Active_not_recruiting)
- Longyan People's Hospital — Longyan, Fujian, China (Active_not_recruiting)
- Nanping Second Hospital — Nanping, Fujian, China (Recruiting)
- Mindong Hospital of Ningde City — Ningde, Fujian, China (Recruiting)
- Ningde City Hospital — Ningde, Fujian, China (Active_not_recruiting)
- Affiliated Hospital of Putian University — Putian, Fujian, China (Active_not_recruiting)
- Putian First Hospital — Putian, Fujian, China (Recruiting)
- Sanming Second Hospital — Sanming, Fujian, China (Recruiting)
- Shenzhen Maternity and child Healthcare Hospital — Shenzhen, Guangdong, China (Recruiting)
- Shijiazhuang Obstetrics and Gynecology Hospital — Shijiazhuang, Hebei, China (Active_not_recruiting)
- Affiliated Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Active_not_recruiting)
- Maternal and Child Health Hospital of Hubei Province — Wuhan, Hubei, China (Active_not_recruiting)
Study contacts
- Study coordinator: Binhua Dong
- Email: dbh18-jy@126.com
- Phone: +86-591-87558732
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.