Research of Multiple Targeting CO2 Laser Ablation for the Treatment of Lower Anogenital Tracts' Precancerous Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pathological cure
研究概览
简要总结
Using multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
详细描述
Patients diagnosed with CIN, VaIN, VIN, AIN or PAIN are recruited with exclusion of suspicion of malignant tumors. We use multiple targeting CO2 laser ablation to treat the precancerous lesion of the female lower anogenital tracts and then follow up the patients for at least two years. By analyzing the data collected in the study, we aim to form the standard strategy of laser ablation method to increase the effective rate and lower the rate of relapse and progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Had the history of sexual life.
- •Transferred to colposcopy examination and biopsy for abnormal screening of cervical cancer, contact bleeding of cervix, recurrent discomfort of vulva or abnormal signs of lower genital and anal tract. The pathology of biopsy indicate CIN, VaIN, VIN, AIN, or PaIN.
- •If CIN, the colposcopy manifests transformation zone-1 which means the lesion can totally be seen. However the consideration of fertility damage of resection overweighs the chance of suffering cancer.
- •The patients can accept multiple laser ablations and colposcopy examinations and follow-up at least 2 years.
排除标准
- •Patients who are suffering cancers of other systems and in treatment.
- •Patients suffering acute inflammation of lower genital and anal tracts.
- •The colposcopy and pathology examination suspect of cancer of lower genital and anal tract.
- •Patients suffering severe diseases such as insufficiency of liver and kidney function, diseases of blood system and other acute infections who will get heath harm from colposcopy and laser vaporization.
结局指标
主要结局
Pathological cure
时间窗: up to at least two years
No squamous intraepithelial lesions found by pathological examinations.
次要结局
- HPV clearance(Every six months after initial treatment for at least two years)