Understanding HPV Viral Load and Its Role in Recurrence of High-Grade Cervical Lesions
Official title: A Multicenter Cohort Study of HPV Viral Load in Predicting the Postoperative Recurrence of Women With HSIL in Cervix
Run by Fujian Maternity and Child Health Hospital · NCT05282745 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
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 |
|---|---|
| Ages | 20 Years and up |
| Sex | Women only |
| Enrollment | 4000 (estimated) |
| Sponsor | Fujian Maternity and Child Health Hospital Academic / other |
| Locations | 10 sites (Fuzhou, Fujian and 9 other locations) |
| Trial ID | NCT05282745 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 20 and over with a recent diagnosis of high-grade squamous intraepithelial lesion (HSIL).
✕Probably not a fit
Patients who have undergone HPV vaccination or have a history of cervical surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have indicated a correlation between HPV viral load and cervical lesions, suggesting that this approach has potential based on existing evidence.
Who can join: the full rules
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 it's running
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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
Show 4 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Risk of cervical cancer after HPV detection in healthy women
This study tests how likely it is for cervical cancer to develop after different HPV detection patterns in healthy women who undergo HPV-based screening.
-
Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes
This trial tests whether nightly Dysplasix™ vaginal suppositories can clear high‑risk HPV and help mild cervical cell changes (ASC‑US or LSIL) in adult women.
-
At-home HPV self-collection kits for cervical cancer screening
We are testing different ways to give at-home HPV self-collection kits to under-screened people aged 25–65 to see if more of them complete cervical cancer screening and follow-up.
-
Comparing clinic-only versus clinic plus community outreach to offer HPV self-collection for cervical screening in women with HIV
This project will test whether adding community health worker outreach to clinic services helps more women living with HIV complete HPV self-collection for cervical screening.
-
CHW4CervixHealth: HPV self-collection kits with community health workers
This project will test whether giving self-collection HPV kits during community workshops led by community health workers helps increase screening among under-screened women aged 25–65 and will first compare kit results to clinical Pap smears.
-
Q-Pad menstrual-pad test to detect high-risk HPV and cervical precancer
This study tests whether a home menstrual-pad kit (Q-Pad) can detect high-risk HPV and cervical precancer in people referred for colposcopy after an abnormal Pap or HPV result.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.