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NCT07885566

RWS of PDT for CIN 2

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Real-World Study of Photodynamic Therapy for Cervical Intraepithelial Neoplasia Grade 2

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2028-06

Completion Date

2029-03

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Interventions

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.

Inclusion Criteria: Participants must meet all of the following criteria: 1. Female participants aged 18 to 50 years. 2. Histologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2). 3. Colposcopy demonstrates a fully visible transformation zone and the upper margin of the lesion (transformation zone type 1 or 2). 4. Positive HPV test result. 5. Treatment with photodynamic therapy (PDT) that is approved for the treatment of CIN2 in routine clinical practice. Exclusion Criteria: Participants meeting any of the following criteria will be excluded: 1. Histologically confirmed or highly suspected cervical invasive cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion. 2. Current pregnancy or breastfeeding, or plans to become pregnant during the study period through 3 months after the last PDT treatment. 3. Any contraindication to PDT, including: * Cervical invasive cancer, adenocarcinoma in situ, endocervical intraepithelial neoplasia, or other glandular epithelial lesions; * A history of toxic shock syndrome; * Porphyria; * Known hypersensitivity to hexyl 5-aminolevulinate, aminolevulinate derivatives, or any excipients; * Severe gynecological infection identified by colposcopy or clinical examination; * Menstruation or vaginal bleeding; * Silicone allergy; * Presence of a cardiac pacemaker; * Cervical anatomical abnormalities or incomplete cervical anatomy resulting from previous surgery that prevent use of the single-use cervical PDT lamp; * Delivery or abortion within 6 weeks before enrollment. 4. Any cervical treatment within 3 months before enrollment, including but not limited to loop electrosurgical excision procedure (LEEP), cold-knife conization, ablation, cryotherapy, or other local physical or chemical treatment. 5. Known severe immunodeficiency, such as active acquired immunodeficiency syndrome (AIDS), uncontrolled autoimmune disease, or long-term systemic treatment with immunosuppressive agents (continuous use for 2 weeks or longer), chemotherapy, or other treatments that, in the investigator's judgment, may substantially affect immune status or interfere with assessment of treatment effectiveness. 6. Any other condition that, in the investigator's medical judgment, may expose the participant to unacceptable risk or substantially interfere with data collection or interpretation.