RWS of PDT for CIN 2

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is a prospective, observational, multicenter real-world study designed to evaluate the effectiveness and safety of photodynamic therapy (PDT) in women with cervical intraepithelial neoplasia grade 2 (CIN2). Approximately 1,000 women aged 18 to 50 years with biopsy-confirmed CIN2 and a positive human papillomavirus (HPV) test will be enrolled. Participants will receive PDT that is approved for the treatment of CIN2 in routine clinical practice. Treatment will be administered according to the approved product labeling and the treating physician\'s clinical judgment. As this is an observational real-world study, the number and timing of PDT treatments will not be prespecified and will be recorded according to routine clinical practice. Participants will be followed for 12 months after the initial PDT treatment. The primary outcome is the pathological remission rate at 6 months after the initial PDT treatment. Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/low-grade squamous intraepithelial lesion (LSIL). Secondary outcomes include HPV clearance rates at 3 and 6 months, the incidence and severity of treatment-related adverse events, and the pathological remission rate at 12 months. Exploratory analyses will evaluate the association between available HPV-related biomarkers, including HPV integration status, and treatment outcomes.
Epistemonikos ID: db059739576897a5b6b9bfb5c8f6ff00c847521a
First added on: Oct 22, 2026