RWS of PDT for CIN 2

NCT07885566 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202609064
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cervical Intraepithelial Neoplasia Grade 2 (CIN2)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months after the initial PDT treatment

Secondary Outcomes (4)

• HPV Clearance Rate at 3 Months

  3 months after the initial PDT treatment

• HPV Clearance Rate at 6 Months

  6 months after the initial PDT treatment

• Incidence and Severity of Treatment-Related Adverse Events

  From the first PDT treatment through the 12-month follow-up period

• Pathological Remission Rate at 12 Months

  12 months after the initial PDT treatment

Study Arms (1)

CIN2 patients receiving routine clinical PDT

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)

Interventions

Hexaminolevulinate (HAL) COMBINATION_PRODUCT

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.

CIN2 patients receiving routine clinical PDT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participants must meet all of the following criteria:
• Female participants aged 18 to 50 years.
• Histologically confirmed cervical intraepithelial neoplasia grade 2 (CIN2).
• Colposcopy demonstrates a fully visible transformation zone and the upper margin of the lesion (transformation zone type 1 or 2).
• Positive HPV test result.
• Treatment with photodynamic therapy (PDT) that is approved for the treatment of CIN2 in routine clinical practice.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Histologically confirmed or highly suspected cervical invasive cancer, adenocarcinoma in situ, or high-grade glandular intraepithelial lesion.
• Current pregnancy or breastfeeding, or plans to become pregnant during the study period through 3 months after the last PDT treatment.
• 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.
• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

5-aminolevulinic acid hexyl ester

Central Study Contacts

Nan Yu

CONTACT

+86-027-83663636; nny86@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): June 1, 2028
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share