A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Regresson of CIN1 to a normal biopsy
研究概览
简要总结
Based on the high incidence of cervical cancer and high grade dysplasia and increased progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the effect of cryotherapy among HIV-positive women diagnosed with CIN 1 versus regular 12 month cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have had a colposcopic biopsy for persistent LSIL as per standard of care.
详细描述
Women with HIV have a higher risk of cervical cancer. Screening and treatment formaly of the disease is limited die to poor access of screening programs and multiple visits. Women with HIV also have high progressions rates of disease amd my need to be treated earliers. Cryotherapy is a low option and very easy to implement especially in low resource provinces.
- It is cheaper and easier to administer than Large Loop electrosurgical excision procedure (LLETZ)
- No histology or transportation costs of specimens
- Less invasive than LLETZ
- It is nurse driven and easily learned
- It decreases loss to follow-up of patients due to reduced waiting time, transportation costs, time off work and HIV stigma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •HIV -infected women whose biopsy proves CIN1 and who consent to study participants and procedures
- •CIN1 with no visible lesion
- •The entire ectocervical lesion should cover less than 75% of the cervix and not more than 2 - 3mm into the endocervical canal
排除标准
- •Pregnant women
- •Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy)
- •Women who are menstruating or who have active pelvic inflammatory disease will be deferred from the study until the infection is cleared or the menstrual cycle has ended; the patient may then participate in the study.
- •Unsatisfactory colposcopic examination defined as inability to see the extent of the lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an OB/GYN specialist.
- •Previous hysterectomy with removal of the cervix
结局指标
主要结局
Regresson of CIN1 to a normal biopsy
时间窗: 12 month
Treatment failure is the progression of CIN1 to CIN2
次要结局
未报告次要终点
研究者
Cynthia S Firnhaber
Associate Professor of Medicine
University of Witwatersrand, South Africa