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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Regression of Cervical Lesions.
研究概览
简要总结
Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.
详细描述
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 lesions associated with high-risk HPV infection lasting more than one year. The study's primary objective is to assess which treatment option yields better results. Participants in both groups will undergo specific therapeutic procedures, including 5-ALA photodynamic therapy or CO2 laser treatment. The study will analyze and compare the effects of these therapies on the regression or elimination of cervical lesions, offering valuable insights into the management of persistent low-grade cervical lesions among high-risk HPV-infected women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Regression of Cervical Lesions.
时间窗: Assessed at 6 months after the last PDT session.
Measure the rate of regression in cervical lesions after three PDT sessions.
次要结局
- Adverse Events.(Evaluated at 6 months after the CO2 laser treatment.)
研究者
YANHU
director
First Affiliated Hospital of Wenzhou Medical University