Status:
RECRUITING
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
HPV-Related Cervical Carcinoma
Low-Grade Squamous Intraepithelial Lesions
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.
Detailed Description
This non-randomized controlled trial aims to compare the effectiveness of two treatments, 5-aminolevulinic acid (5-ALA) photodynamic therapy and CO2 laser, for women with persistent low-grade cervical...
Eligibility Criteria
Inclusion
- Aged 18-65 years old with a history of sexual activity.
- Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6/E7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).
- Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.
- No fundamental diseases of important organs.
- Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form.
- There has been no history of using other drugs related to HPV infection in the past 3 months.
Exclusion
- HR-HPV persistent infection.
- A total hysterectomy has been performed.
- Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.
- Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).
- Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.
- Pregnant and lactating women.
- Acute reproductive tract inflammation.
- Diabetes patients with uncontrolled blood sugar.
- Patients who do not receive full treatment and follow-up.
- Those who fail to sign the informed consent form.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06052033
Start Date
September 11 2023
End Date
June 30 2025
Last Update
May 13 2025
Active Locations (1)
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1
first affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, China, 325015