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NCT Number: NCT07009327

Efficacy and Safety of Photodynamic Therapy for CIN3

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

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Key information

Conditions

Precancerous Cervical Lesion

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Unniversity Third Hospital

Beijing, 100191, China

Location status: Recruiting

Location contact

Qin Han

CONTACT

[email protected]

13810632686

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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；

Treatment and study plan

ALA-PDT

Procedure

use ALA_PDT to treat the disease

Primary outcomes

  1. Efficacy of the treatment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qin Han

CONTACT

[email protected]

13810632686

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Efficacy and Safety of Photodynamic Therapy for Cervical Intraepithelial Neoplasia 3(CIN3):A Multicenter Prospective Cohort Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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