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Recruiting NCT07009327

Efficacy and Safety of Photodynamic Therapy for CIN3

No phase Interventional Precancerous Cervical Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALA-PDT.
Who it may be relevant to
Registry conditions: Precancerous Cervical Lesion. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Procedure ALA-PDT
    use ALA\_PDT to treat the disease

Primary outcome measures

  • Efficacy of the treatment [Time frame: 1 month after the treatment]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Unniversity Third Hospital — Beijing

Identifiers

NCT: NCT07009327 · PDT-CIN3 · 2022YFB3604704

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗