Multicenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-60
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

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

225 Participants
are divided into 2 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