CIN 2, HPV (Human Papillomavirus)-Associated, HSIL, High Grade Squamous Intraepithelial Lesion, Photodynamic Therapy (PDT)
Conditions
Keywords
photodynamic therapy, High Grade Squamous Intraepithelial Lesion, human papillomavirus, loop electrosurgical excision procedure, efficacy
Brief summary
This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
Detailed description
This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.
Interventions
PROCEDUREALA-PDT
Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.
PROCEDURELEEP surgery
After anesthesia, cervical iodine staining was performed, followed by LEEP.
Sponsors
Women's Hospital School Of Medicine Zhejiang University
First People's Hospital of Hangzhou
First Affiliated Hospital of Ningbo University
Shaoxing People's Hospital
Linping First People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female, 25-60 years, understands study procedures and consents to participate; 2. Colposcopy-guided cervical biopsy within 3 months showing HSIL/CIN2; 3. Provides written informed consent.
Exclusion criteria
1. Cytology showing ASC-H, HSIL, AGC, or AIS; or evidence of malignant cells on cytology/histology, or suspicion of malignancy or invasive cancer; 2. Colposcopy findings suggestive of invasive cancer or lesion extension to the vaginal wall; 3. Severe pelvic, cervical, or other gynecological inflammatory conditions identified clinically; 4. Undiagnosed vaginal bleeding; 5. Active allergic disease, porphyria, or history of allergy to the study drug or structurally similar agents; 6. Severe cardiovascular, neurological, psychiatric, endocrine, hepatic, or hematologic disorders; known immunodeficiency; long-term glucocorticoid or immunosuppressant use; active autoimmune disease; or other malignancies; 7. Pregnant or breastfeeding women; 8. History of hysterectomy, cervical cancer treatment, or cervical excision/ablation within 6 months (e.g., conization, LEEP, laser); 9. Use of interferon or antiviral therapy within 3 months; 10. Any other condition deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion effective rate | 6 months | Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion effective rate | 2 years | Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 12 and 24 months post-treatment. |
| HPV clearance rate | 2 years | HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment |
| Lesion cure rate | 2 years | Proportion of patients with normal colposcopy-guided cervical biopsy results and negative HPV |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact on cervical anatomy and function | 2 years | Cervical length and function before and after treatment, and subsequent pregnancy outcomes in patients desiring fertility. |
| Adverse events | 2 years | Record post-treatment adverse events including bleeding, infection, and pain. |
Countries
China
Contacts
Primary ContactXiaoyun Wang, Doctor
Outcome results
None listed