Clinical trial · Interventional
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia
Efficacy and Safety of Photodynamic Therapy for Cervical and Vaginal Intraepithelial Neoplasia:A Multicenter Prospective Cohort Study
NCT06982976CI-TRIAL-00089998recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Precancerous Cervical Lesion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALA-PDT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ALA-PDT
- description
- Patients choose PDT to treat the disease
- interventionNames
- Procedure: ALA-PDT
Primary outcomes (1)
- measure
- Efficacy of the treatment
- timeFrame
- 1 month after the treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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；
References
Publications (0)
Data not yet available
No reference posted for this study.