Cervical Intraepithelial Neoplasia Clinical Trial
Official title:
A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
Verified date | July 2019 |
Source | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).
Status | Completed |
Enrollment | 60 |
Est. completion date | November 24, 2018 |
Est. primary completion date | November 24, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Premenopausal women, 25-50 years of age - Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months - Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) - Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study - Written informed consent signed Exclusion Criteria: - ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease - Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy - Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination - Undiagnosed vaginal bleeding - With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues - With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions; patients with malignant tumors - Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN) - Pregnancy or nursing - Previous physical therapy of LSIL/CIN1 after pathologic diagnosis - Participation in any clinical studies within the last 30 days - Subjects that the investigators judged to be not suitable to participate the study besides above |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
China | Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | The Obstetrics & Gynecology Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Based on histology, cytology and HPV status. "Response" is defined as: 1) pathology and cytology were both normal; 2) pathology and/or cytology showed low grade and the baseline HPV infection was cleared. | 3 months after treatments | |
Primary | Complete response rate | Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV. | 3 months after treatments | |
Primary | Clearance of high risk HPV | Proportion of patients with high risk HPV clearance | 3 months after treatments |
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