Understanding HPV Viral Load and Its Role in Recurrence of High-Grade Cervical Lesions
A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of Women With HSIL in Cervix
This study is trying to see if the amount of HPV virus in women with high-grade cervical lesions can help predict if their condition will come back after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Fujian Maternity and Child Health Hospital Academic / other |
| Locations | 10 sites (Fuzhou, Fujian and 9 other locations) |
| Trial ID | NCT05282745 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to investigate the relationship between HPV viral load and the recurrence of high-grade squamous intraepithelial lesions (HSIL) in women. Conducted across multiple centers in China, the study will enroll 4,000 women diagnosed with HSIL, collecting cervical and vaginal samples at baseline and during follow-up visits at 6, 12, and 24 months. The samples will undergo various tests, including PCR-sequencing and HPV testing, to assess the correlation between viral load and disease progression. The findings could provide insights into the predictive value of HPV load for monitoring HSIL recurrence.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 and over with a recent diagnosis of high-grade squamous intraepithelial lesion (HSIL).
Not a fit: Patients who have undergone HPV vaccination or have a history of cervical surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict and manage the recurrence of high-grade cervical lesions in women.
How similar studies have performed: Previous studies have indicated a correlation between HPV viral load and cervical lesions, suggesting that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 20 and over. * The result of cervical histopathology in the last 3 months was high-grade squamous intraepithelial lesion (HSIL). * Non pregnant people with sexual history. * 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 9 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)
- Zhangzhou affiliated Hospital of Fujian Medical University — Zhangzhou, Fujian, China (Recruiting)
- Longyan First Hospital — Longyan, China (Recruiting)
- Shenzhen Maternity and child Healthcare Hospital — Shenzhen, China (Recruiting)
- Maternity and child Hospital of Hubei Province — Wuhan, China (Recruiting)
- Xiamen Maternity and Child Health Hospital — Xiamen, 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.