This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
This study is a multicenter, prospective, concurrent, non-randomized controlled clinical trial designed to evaluate the clinical efficacy of ALA-PDT treatment compared with observation and follow-up in patients with cervical low-grade squamous intraepithelial lesion (LSIL) associated with HPV16/18 infection. The primary outcome is the cervical lesion reversal rate. Secondary outcomes include HPV16/18 clearance rate and time to clearance, as well as improvements in cervical ectropion and vaginal microenvironment. Additionally, lesion progression rate and recurrence rate will be monitored in both groups. Safety, tolerability, patient-reported quality of life, and treatment satisfaction are also assessed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, China
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Hangzhou Linping District first People's Hospital
Hangzhou, Zhejiang, China
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Cervical lesion regression rate
Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment.
Time frame: 6 months
HPV clearance rate
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
Time frame: 2 years
Cervical lesion regression rate
Proportion of patients with normal colposcopy-guided cervical biopsy histopathology, or NILM cytology plus negative HPV test, at 12 and 24 months.
Time frame: 2 years
Jianwei Zhou, Professor
CONTACT
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Shaoxing People's Hospital
Shaoxing, Zhejiang, China