Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cervical persistent high risk HPV infection | Experimental | Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection |
|
| CIN 1 with high risk HPV infection | Experimental | Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 1 and high risk HPV infection |
|
| CIN 2/3 | Experimental | Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolaevulinic acid photodynamic therapy | Drug | Aminolaevulinic acid mediated photodynamic therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Based on histology | 3 months after treatments |
| clearance of high risk HPV | proportion of patients with high risk HPV clearance | 3 months after treatments |
Not provided
Not provided
Inclusion Criteria:
Premenopausal women, 25-50 years of age
Meet one of the 3 following conditions:
high-risk HPV-DNA persistently positive for at least 6 months, without CIN or higher grade lesions as verified by cervical biopsy within the last 3 months; CIN1 as verified by cervical biopsy within the last 3 months and high-risk HPV-DNA positive; CIN2/3 as verified by cervical biopsy within the last 3 months, with intense desire to retain the cervical structure or function
Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin ) and endocervical curettage negative
In good health condition as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation within the last 4 weeks of the onset of the study
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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, Master | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | 210036 | China | ||
| Qilu Hospital of Shandong University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
Not provided
Not provided