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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALA | Experimental | Patients will receive 3 topical treatments of aminolaevulinic acid 500mg |
|
| Placebo | Placebo Comparator | Patients will receive 3 topical treatments of placebo 500mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolaevulinic acid | Drug | Aminolaevulinic acid with illumination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Clearance of high risk HPV | Proportion of patients with high risk HPV clearance | 3 months after treatments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beihua Kong, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Youzhong Zhang, MD | Qilu Hospital of Shandong University | Principal Investigator |
| Jining Tao | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China | ||
| Qilu Hospital of Shandong University |
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| Placebo |
| Drug |
Placebo with illumination |
|
| Jinan |
| Shandong |
| 250012 |
| China |
| The Obstetrics & Gynecology Hospital of Fudan University | Shanghai | Shanghai Municipality | 200011 | China |
| Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang | 310006 | China |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D000081483 | Squamous Intraepithelial Lesions |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C428044 | 5-aminolaevulinic acid-n-pentylester |
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