Recruiting NCT06982976
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia
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 →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia: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 and vaginal intraepithelial neoplasia 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
- 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；
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: NCT06982976 · IRB00006761-M2023505 · 2022YFB3604704