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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06467942
Other study ID # ELIM-HPV2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source Peking University People's Hospital
Contact Mingzhu Li, doctor
Phone 86+15910691947
Email mingzhu1815@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

High risk human papillomavirus (hr-HPV) persistent infection is a high risk factor for cervical cancer. 85% to 90% of hr-HPV infections have the ability to clear on their own, while 10% to 15% of HPV persists further will lead to the development of high-grade intraepithelial lesions (HSIL) and even to invasive cervical cancer. Long-term follow-up results for persistent hr-HPV infection showed that cervical HSIL mostly occurred after 5-7 years of persistent hr-HPV infection, among which the risk of HPV16 and 18 was the highest, followed by HPV31 and 33. The role of the vaginal microbiome (CVM) in persistent hr-HPV infection has been increasingly valued, and women with persistent HPV infection that progresses to HSIL have a more unstable vaginal microenvironment. The previous study found that Lactobacillus vaginalis may contribute to HPV clearance by improving the vaginal microenvironment. In addition, previous studies have found that estrogen-like Chinese medicine could increase glycogen, improve mucosal estrogen levels, increase lactobacillus content, and promote HPV clearance. It is a challenge to make clinical management on when and how to intervene among hr-HPV persistent infection but whose pathology does not suggest HSIL. This study intends to analyze the correlation between the duration of HPV infection and the current vaginal microbiome, HPV load and PAX1 methylation in people with persistent HPV infection at different ages, and observe the changes of the above indicators after the administration of drugs to improve the vaginal microenvironment, which is helpful for preventing HPV persistent infection and developing into true precancerous lesions. It has the clinical and practical value of "preparing for a rainy day".


Description:

1. Correlation of Previous Persistent HPV Infection Duration with Current CST, HPV Load, and PAX1 Methylation Participants: Select 240 women aged 25 and above who have had persistent high-risk HPV infection of the same type for 1 year or more but whose pathology does not indicate HSIL. Data Recording: Record the time of first confirmed HPV infection based on test reports. Initial Testing: After meeting the inclusion criteria, conduct initial tests for vaginal microbiota types (CST), HPV load, and PAX1 methylation. Correlation Analysis: Analyze the correlations based on different ages, menopausal status, and duration of HPV infection. 2. Changes in CST, HPV Load, and PAX1 Methylation After Treatment to Improve Vaginal Microenvironment Study Design: Conduct a double-blind randomized medication trial with the participants divided into four groups: Traditional Chinese Medicine Group: 10 days Lactobacillus Group: 10 days Combination Group: Traditional Chinese Medicine for 5 days + Lactobacillus for 5 days Control Group: Observation only, no medication Pre-Treatment: If applicable, treat any existing vaginitis before assigning medications. Medication Regimen: Administer 10 consecutive days of vaginal medication each month, pausing during menstruation and resuming post-menstruation to complete the 10-day course. Sexual intercourse is prohibited during the medication period. Follow-Up Testing: Conduct CST, HPV load, and PAX1 methylation tests at 6 and 12 months post-treatment. Progression Monitoring: If HPV remains positive upon retesting, perform a colposcopy. Terminate the study and provide appropriate treatment if pathology progresses to HSIL.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility Inclusion Criteria: - Women over 25 years of age with the same type of high-risk HPV infection lasting for more than 1 year, atypical squamous cell (ASCUS) or Low-grade squamous intraepithelial disease (LSIL) cytologically negative or undiagnosable, and pathological biopsy results negative or LSIL - Consent to use the device for contraception during the study period; - agree with medicine and follow-up management procedure. Exclusion Criteria: - High cytological risk, including atypical squamous cells (ASC-H),HSIL and atypical glandular cell (AGC), which could not rule out high-grade squamous intraepithelial lesions; - pathological biopsy for HSIL and above; - for any drug allergies; - pregnancy or lactation

Study Design


Intervention

Drug:
Chinese medicine and Lactobacillus
combined drug group
Chinese medicine
Single Chinese medicine group
Lactobacillus
Single Lactobacillus group

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary community state type (CST) Vaginal microflora type Change of CST at 6 months and 12 months after medication
Primary HPV VL HPV viral load Change of HPV VL at 6 months and 12 months after medication
Primary PAX1 methylation test Pairing box gene1 methylation test Change of PAX1 methylation test at 6 months and 12 months after medication
Secondary Complete remission (CR) HPV subtypes with persistent infection turned negative at 6 and 12 months or positive at 6 months, and negative at 12 months Change of CR at 6 months and 12 months after medication
Secondary Partial remission (PR) Partial response (PR) : HPV subtypes with persistent infection turned negative at 6 months and returned positive at 12 months Change of PR at 6 months and 12 months after medication
Secondary No response (NR) HPV subtypes with persistent infection were positive at both follow-up visits Change of NR at 6 months and 12 months after medication
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