HPV-16/18, Photodynamic Therapy (PDT), LSIL, Low Grade Squamous Intraepithelial Lesion
Conditions
Keywords
cervical low-grade squamous intraepithelial lesions, aminolevulinic acid-mediated photodynamic therapy, efficacy, human papillomavirus
Brief summary
This multicenter, prospective trial assesses ALA-PDT versus observation for efficacy and safety in treating cervical LSIL with HPV16/18 infection.
Detailed description
This study is a multicenter, prospective, concurrent, non-randomized controlled clinical trial designed to evaluate the clinical efficacy of ALA-PDT treatment compared with observation and follow-up in patients with cervical low-grade squamous intraepithelial lesion (LSIL) associated with HPV16/18 infection. The primary outcome is the cervical lesion reversal rate. Secondary outcomes include HPV16/18 clearance rate and time to clearance, as well as improvements in cervical ectropion and vaginal microenvironment. Additionally, lesion progression rate and recurrence rate will be monitored in both groups. Safety, tolerability, patient-reported quality of life, and treatment satisfaction are also assessed.
Interventions
PROCEDUREALA-PDT
Photosensitizer is applied to the cervical canal and cervix, followed by light irradiation, repeated every 7-14 days for 3-6 sessions.
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
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female, 20-60 years, understands study procedures and consents to participate; 2. HPV 16 or 18 positive; 3. Colposcopy-guided cervical biopsy within 3 months showing LSIL; 4. 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 |
|---|---|---|
| Cervical lesion regression rate | 6 months | Proportion of patients with normal histopathology on colposcopy-guided biopsy or NILM cytology, plus negative HPV test, at 6 months post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HPV clearance rate | 2 years | HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment |
| Cervical lesion regression rate | 2 years | Proportion of patients with normal colposcopy-guided cervical biopsy histopathology, or NILM cytology plus negative HPV test, at 12 and 24 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 years | Record post-treatment bleeding, pain, and photosensitivity. |
Countries
China
Contacts
Primary ContactXiaoyun Wang, Doctor
Backup ContactJianwei Zhou, Professor
Outcome results
None listed