Efficacy and Safety of Photodynamic Therapy for CIN3

Not Applicable

Recruiting

• Conditions: Precancerous Cervical Lesion

• Registration Number: NCT07009327
• Lead Sponsor: Peking University Third Hospital

Brief Summary

To investigate the efficacy and safety of photodynamic therapy (20% 5-amino-ketovalerate 630nm red light) in the treatment of cervical intraepithelial neoplasia 3(CIN 3)in women in the real world

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• CIN3, photodynamic therapy was required,
• type 1 2 transformation area, colposcopy was sufficient
• the lesion boundary was completely visible
• The ECC did not indicate high-grade lesions

Exclusion Criteria

• coexistence or suspicion of cancer;
• TCT HSIL
• involving glands
• Porphyria patients, or suspected allergic to red and blue light.
• severe medical comorbidities；

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy of the treatment	1 month after the treatment	colposcopy and biopsy will be performed one month after the treatment. Patients will be categorised as having complete remission(CR) if biopsy confirmed LSIL. If CIN 2 was found after the first course of PDT, it would be categorised as partial remission(PR). Those with the same grade were categorised as persistent disease(PD).; The proportion of CR after PDT treatment.

Trial Locations

Locations (1)

Peking Unniversity Third Hospital; 🇨🇳 Beijing, China