Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia:A Multicenter Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Efficacy of the treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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；
Arms & Interventions
ALA-PDT
Patients choose PDT to treat the disease
Intervention: ALA-PDT (Procedure)
Outcomes
Primary Outcomes
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/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 Outcomes
No secondary outcomes reported