NCT02304770已完成2 期
A Pilot Study of Aminolaevulinic Acid (ALA) Photodynamic Therapy (PDT) in Patients With Cervical Persistent High Risk HPV Infection or Cervical Intraepithelial Neoplasia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- Response Rate
研究概览
简要总结
The study will examine the effect of aminolaevulinic acid (ALA) photodynamic therapy (PDT) of cervical precancerous lesions in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Atypical glandular cells of undetermined significance (AGUS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- •Invasive carcinoma possibility or positive endocervical curettage 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 similar compounds
- •Evidence or history of clinically significant cardiovascular, endocrine, neurologic, pulmonary, hematological, immunological, psychiatric, metabolic disease or other serious diseases
- •Pregnancy or nursing
- •Therapeutic drug or other therapeutic measures applied on cervix or rectum within the last 2 weeks of the onset of the study
- •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
研究组 & 干预措施
cervical persistent high risk HPV infection
Experimental
Aminolaevulinic acid photodynamic therapy for the treatment of patients with cervical persistent high risk HPV infection
干预措施: Aminolaevulinic acid photodynamic therapy (Drug)
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
干预措施: Aminolaevulinic acid photodynamic therapy (Drug)
CIN 2/3
Experimental
Aminolaevulinic acid photodynamic therapy for the treatment of patients with CIN 2/3
干预措施: Aminolaevulinic acid photodynamic therapy (Drug)
结局指标
主要结局
Response Rate
时间窗: 3 months after treatments
Based on histology
clearance of high risk HPV
时间窗: 3 months after treatments
proportion of patients with high risk HPV clearance
次要结局
未报告次要终点
研究者
研究点 (4)
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