HPV viral load's role in predicting outcomes for women with low-grade cervical lesions
A Multicenter Cohort Study of HPV Viral Load in Predicting the Prognosis of Women With LSIL in Cervix
This study is trying to see if measuring the amount of HPV in women with low-grade cervical lesions can help predict how their condition will change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Fujian Maternity and Child Health Hospital Academic / other |
| Locations | 8 sites (Fuzhou, Fujian and 7 other locations) |
| Trial ID | NCT05051852 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between HPV viral load and the prognosis of low-grade squamous intraepithelial lesions (LSIL) in women. Conducted across multiple centers in Fujian Province, China, the study will enroll 3,000 women diagnosed with LSIL, collecting cervical and vaginal samples at various intervals to monitor disease progression. The samples will undergo PCR-sequencing and HPV testing to assess the correlation between viral load and the severity of cervical lesions. The findings aim to enhance understanding of HPV's impact on cervical health and inform clinical decision-making.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 and over with a recent diagnosis of low-grade squamous intraepithelial lesion (LSIL).
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 improve the ability to predict disease progression in women with LSIL, leading to better management and treatment strategies.
How similar studies have performed: Previous studies have indicated a correlation between HPV viral load and cervical lesion severity, suggesting that this approach has potential based on existing research.
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 low-grade squamous intraepithelial lesion (LSIL). * 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 7 other locations
- Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (Recruiting)
- Mindong Hospital of Ningde City — Ningde, 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)
- Shunde Women's and Children's Hospital of Guangdong Medical University — Foshan, Guangdong, China (Recruiting)
- Maternal and Child Health Hospital of Shenzhen Province — Shenzhen, Guangdong, China (Recruiting)
- Maternal and Child Health Hospital of Hubei Province — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Binhua Dong
- Email: dbh18-jy@126.com
- Phone: +8613599071900
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.