Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia
Not Applicable
Recruiting
- Conditions
- Precancerous Cervical Lesion
- Registration Number
- NCT06982976
- 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 and vaginal intraepithelial neoplasia in women in the real world.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 250
Inclusion Criteria
- cervical/vaginal high-grade squamous intraepithelial lesions (HSILs) confirmed by colposcopy and pathological biopsy (CIN2 /CIN3 and/or VaIN2/ VaIN3) or persistent CIN1/VaIN1 lasting for more than one year with a strong willingness to treat;
- colposcopy was adequate, and analysable colposcopy images were retained;
- endocervical curettage (ECC) did not suggest higher-grade lesions.
Exclusion Criteria
- coexistence or suspicion of cancer;
- porphyria or suspected allergies 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/VAIN 2 was found after the first course of PDT, it would be categorised as partial remission(PR) if they are CIN3/VAIN3 before treatment. Those with the same grade were categorised as persistent disease(PD).
The proportion of CR and PR after PDT treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking Unniversity Third Hospital
🇨🇳Beijing, Beijing, China