Comparing two treatments for persistent low-grade cervical lesions caused by high-risk HPV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-randomized controlled trial compares the effectiveness of 5-aminolevulinic acid (5-ALA) photodynamic therapy and CO2 laser treatment for women with persistent low-grade cervical lesions associated with high-risk HPV infection lasting over one year. The study aims to determine which treatment option is more effective in regressing or eliminating these cervical lesions. Participants will receive either 5-ALA photodynamic therapy or CO2 laser treatment, and the outcomes will be analyzed to provide insights into managing these conditions. The trial is designed to enhance understanding of treatment efficacy for women affected by high-risk HPV.

Why it matters

Who can join: the full rules

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.

Where it's running

• first affiliated hospital of Wenzhou medical university
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Yan Hu, Phd
• Email: 627830566@qq.com
• Phone: 008613806696807

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• 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.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.