HPV Infection Clinical Trial
Official title:
The Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus C02 Laser in the Treatment of Persistent Cervical Low-grade Squamous Intraepithelial Lesions With High-risk HPV Infection:A Non-randomized Controlled Trail Study
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 1, 2024 |
Est. primary completion date | August 10, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Aged 18-65 years old with a history of sexual activity. 2. 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). 3. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year. 4. No fundamental diseases of important organs. 5. Agree to receive treatment and/or follow-up according to regulations and sign an informed consent form. 6. There has been no history of using other drugs related to HPV infection in the past 3 months. Exclusion Criteria: 1. HR-HPV persistent infection. 2. A total hysterectomy has been performed. 3. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors. 4. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE). 5. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids. 6. Pregnant and lactating women. 7. Acute reproductive tract inflammation. 8. Diabetes patients with uncontrolled blood sugar. 9. Patients who do not receive full treatment and follow-up. 10. Those who fail to sign the informed consent form. |
Country | Name | City | State |
---|---|---|---|
China | first affiliated hospital of Wenzhou medical university | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Wenzhou Medical University |
China,
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Fu Y, Bao Y, Hui Y, Gao X, Yang M, Chang J. Topical photodynamic therapy with 5-aminolevulinic acid for cervical high-risk HPV infection. Photodiagnosis Photodyn Ther. 2016 Mar;13:29-33. doi: 10.1016/j.pdpdt.2015.12.004. Epub 2015 Dec 10. — View Citation
Hu Z, Li J, Liu H, Liu L, Jiang L, Zeng K. Treatment of latent or subclinical Genital HPV Infection with 5-aminolevulinic acid-based photodynamic therapy. Photodiagnosis Photodyn Ther. 2018 Sep;23:362-364. doi: 10.1016/j.pdpdt.2018.07.014. Epub 2018 Jul 2 — View Citation
Li D, Zhang F, Shi L, Lin L, Cai Q, Xu Y. Treatment of HPV Infection-Associated Low Grade Cervical Intraepithelial Neoplasia with 5-Aminolevulinic Acid-Mediated Photodynamic Therapy. Photodiagnosis Photodyn Ther. 2020 Dec;32:101974. doi: 10.1016/j.pdpdt.2 — View Citation
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Wang X, You L, Zhang W, Ma Y, Tang Y, Xu W. Evaluation of 5-aminolevulinic acid-mediated photodynamic therapy on cervical low-grade squamous intraepithelial lesions with high-risk HPV infection. Photodiagnosis Photodyn Ther. 2022 Jun;38:102807. doi: 10.10 — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Regression of Cervical Lesions. | Measure the rate of regression in cervical lesions after three PDT sessions. | Assessed at 6 months after the last PDT session. | |
Secondary | Adverse Events. | Monitor and document any adverse events or complications related to CO2 laser treatment. | Evaluated at 6 months after the CO2 laser treatment. |
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