HAL-PDT for Cervical Intraepithelial Neoplasia Grade 2
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorPeking Union Medical College Hospital
About this trial
This is a prospective, multicenter real-world study evaluating the effectiveness and safety of hexaminolevulinate photodynamic therapy (HAL-PDT) in patients with cervical intraepithelial neoplasia grade 2 (CIN2). Treatment is guided by colposcopic response: patients receive 2, 3, or 4 sessions of HAL-PDT based on lesion persistence at Day 60 and Day 90 assessments. The primary endpoint is histopathological regression rate at 6 months after first treatment. Secondary endpoints include histopathological regression at 12 months, HPV clearance at 6 and 12 months, and safety. A total of 500 patients will be enrolled.
Eligibility criteria
Qualifiers
Voluntarily participate in this clinical study, fully understand the study content, procedures, and potential adverse reactions, and be able to sign the written informed consent form.
Able to complete the study in accordance with the study protocol.
Female aged ≥18 years and ≤50 years.
Newly diagnosed High-Grade Squamous Intraepithelial Lesion (HSIL), cervical intraepithelial neoplasia grade 2 (CIN2) within 3 months, specifically: CIN2 confirmed by tissue biopsy within 3 months prior to the first treatment.
Disqualifiers
Cervical adenocarcinoma in situ or other glandular lesions, invasive cervical cancer, or suspected malignant lesions.
Lesions extending to the vaginal wall, cervical canal, or vaginal fornix, or lesions located on the vulva.
Prior treatment (surgical or physical therapy) for the condition, or receipt of physical or surgical therapy within 3 months after the current histopathological diagnosis of CIN2.
The date of the first HAL-PDT treatment falls within 7 half-lives of the last antiviral medication.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
500 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov