Efficacy and Safety of Photodynamic Therapy for CIN3

NCT07009327 | Recruiting DMC

• 2 other identifiers: PDT-CIN32022YFB3604704
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Precancerous Cervical Lesion

Keywords

PDT; HPV; CIN 3

Outcome Measures

Primary Outcomes (1)

• Efficacy of 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.

  1 month after the treatment

Study Arms (1)

ALA-PDT

OTHER

Patients choose PDT to treat the disease

Procedure: ALA-PDT

Interventions

ALA-PDT PROCEDURE

use ALA\_PDT to treat the disease

ALA-PDT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Unniversity Third Hospital

Beijing, 100191, China

RECRUITING

Study Officials

• Qin Han

  Peking Unniversity Third Hospital

  STUDY CHAIR

Central Study Contacts

Qin Han

CONTACT

13810632686; Lmlfe_lynn@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 6, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)