About this trial
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Eligibility criteria
Qualifiers
Female, 20-60 years, understands study procedures and consents to participate;
HPV 16 or 18 positive;
Colposcopy-guided cervical biopsy within 3 months showing LSIL;
Provides written informed consent.
Disqualifiers
Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer;
Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall;
Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically;
Undiagnosed vaginal bleeding;
Trial design
Treatments tested in this trial
- ALA-PDT
Treatment groups
Sponsors and collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Collaborator
First People's Hospital of Hangzhou
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
Shaoxing People's Hospital
Collaborator
Linping First People's Hospital
Collaborator