An observational study in Cervical Intraepithelial Neoplasia Grade 2 (CIN2), sponsored by Tongji Hospital. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Tongji Hospital · Observational
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.
Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.
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This is a prospective, multicenter real-world cohort study. The study enrolls women aged 18-50 years with histopathologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2) and positive HPV test. Eligible participants receive photodynamic therapy under routine clinical practice and are followed prospectively for up to 12 months to evaluate the real-world effectiveness and safety of PDT.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Any contraindication to PDT, including:
This cohort consists of female patients aged 18-50 years with histopathologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2) and positive HPV test. All participants receive photodynamic therapy (PDT) approved for CIN2 in routine clinical practice. The decision to administer PDT, as well as treatment times and intervals, are determined by attending clinicians according to product instructions and clinical conditions, not mandated by this study protocol. Baseline and follow-up assessments including TCT, HPV testing, colposcopy-guided biopsy and HPV integration testing will be performed as specified in the study to evaluate real-world effectiveness and safety of PDT.
Combination Product: Hexaminolevulinate (HAL)
Participants will receive photodynamic therapy (PDT) that is approved for the treatment of CIN2 in routine clinical practice. PDT will be administered according to the approved product labeling. The treating physician will determine the actual treatment schedule based on the participant's clinical condition and routine clinical practice. The number and interval of PDT treatments will not be prespecified by the study protocol and will be recorded as administered.
Pathological Remission Rate at 6 Months
Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/low-grade squamous intraepithelial lesion (LSIL). The pathological remission rate is the proportion of participants meeting this definition at 6 months after the initial PDT treatment.
Time frame: 6 months after the initial PDT treatment
HPV Clearance Rate at 3 Months
The proportion of participants with clearance of HPV infection at 3 months after the initial PDT treatment, based on HPV testing.
Time frame: 3 months after the initial PDT treatment
HPV Clearance Rate at 6 Months
The proportion of participants with clearance of HPV infection at 6 months after the initial PDT treatment, based on HPV testing.
Time frame: 6 months after the initial PDT treatment
Incidence and Severity of Treatment-Related Adverse Events
The incidence and severity of adverse events considered related to PDT will be recorded. Adverse event severity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: From the first PDT treatment through the 12-month follow-up period
Pathological Remission Rate at 12 Months
The proportion of participants with pathological remission at 12 months after the initial PDT treatment. Pathological remission is defined as a cervical biopsy showing normal tissue or CIN1/LSIL.
Time frame: 12 months after the initial PDT treatment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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