Impact of HPV Integration on Prognosis in Women with Persistent HR-HPV Infection
Impact of HPV Integration on the Prognosis of Women With Persistent HR-HPV Infection：a Multi-center Cohort Study in China
This study is testing how the presence of HPV in women's bodies affects their health over time, specifically for those with long-lasting high-risk HPV infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | Female |
| Sponsor | Fujian Maternity and Child Health Hospital Academic / other |
| Locations | 11 sites (Fuzhou, Fujian and 10 other locations) |
| Trial ID | NCT05283239 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between HPV integration status and the prognosis of women with persistent high-risk HPV (HR-HPV) infections. A total of 1000 participants with HR-HPV infections lasting over 18 months or with CIN2+ will be recruited from multiple centers. The study will assess HPV integration status and vaginal flora diversity at baseline and at 6, 12, and 24 months to evaluate their influence on disease progression. The goal is to determine the prognostic value of HPV integration and its association with natural outcomes in these women.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant individuals with a persistent HR-HPV infection for more than 18 months or those with CIN2+.
Not a fit: Patients with a history of genital tract tumors, HPV vaccination, or recent treatments for genital infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the prognosis of women with persistent HR-HPV infections, potentially leading to improved management strategies.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have explored HPV integration and its implications, indicating potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non pregnant people with sexual history； * Persistent infection of the same type of HR-HPV for more than 18 months or HR-HPV infection with CIN2 +; * No history of previous surgery at the cervical site. * Asexual life, no vaginal medication or flushing before 72 hours of sampling. Exclusion Criteria: * Within 8 weeks after pregnancy or postpartum. * Patients with history of genital tract tumor. * History of HPV vaccination. * Previous history of hysterectomy, cervical surgery, pelvic radiotherapy Historical. * In recent one month, she has received genital tract infection, HPV or other STDs treatment related to the infection of mycoplasma. * Use antibiotics or vaginal microecological improvement products in recent 1 month.
Where this trial is running
Fuzhou, Fujian and 10 other locations
- Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (Recruiting)
- Mindong Hospital of Ningde City — Ningde, Fujian, China (Recruiting)
- Ningde Municipal Hospital of Ningde Normal University — Ningde, Fujian, China (Recruiting)
- The First Hospital of Putian City — Putian, Fujian, China (Recruiting)
- Quanzhou First Hospital Afflicated to Fujian Medical University — Quanzhou, Fujian, China (Recruiting)
- Xiamen Maternity and Child Health Hospital Affiliated to Xiamen University — Xiamen, Fujian, China (Recruiting)
- Zhangzhou affiliated Hospital of Fujian Medical University — Zhangzhou, Fujian, China (Recruiting)
- Longyan First Hospital — Longyan, China (Recruiting)
- Nanping Second Hospital — Nanjing, China (Recruiting)
- Sanming Second Hospital — Sanming, China (Recruiting)
- Shenzhen Maternity and child Healthcare Hospital — Shenzhen, China (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.