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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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；
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Peking Unniversity Third Hospital
Beijing
Beijing Municipality
Recruiting
More Peking University Third Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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