Precancerous Cervical Lesion
Conditions
Keywords
ALA-PDT, HPV, CIN, VAIN
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.
Interventions
PROCEDUREALA-PDT
use ALA\_PDT to treat the disease
Sponsors
Peking University Third Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactQin Han
Outcome results
None listed