Interferon Alpha Therapy for Cervical CIN I and HPV Infection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pap smear
研究概览
简要总结
Mongolia is a traditionally nomadic and population is scarce in rural areas. Thus, the medical care service is not sufficient. In 2000, Mongolian government has developed and implemented the millennium project in cooperation with WHO. During the years pap smear analysis of implemented in all rural areas and clinicians, lab technicians have been taught for the cervical cancer screening. However, the project has finished in 2015 and the rural and district hospitals has lost the trained professionals. Still the cervical cancer is in second place after liver cancer in women.
The purpose of the study is to identify the type of HPV genotype and to treat the HPV infection by local interferon α2b.
Materials and methods: HPV positive patients will be enrolled to the study. HPV genotype will be determined by the PCR in laboratory. Pap smear will be taken and staged by the CIN. Pathological tissue will be taken under colposcopy with acetic acid test. Follow up visit will be done on 10th, 30th days of the treatment.
At the end of 90th days of treatment, pap and histology test will be repeated and CIN regression or viral eradication will be evaluated.
详细描述
The purpose of the study is to evaluate the efficacy of interferon treatment for HPV infection shedding and early CIN change.
Women aging from 20-40 years will be enrolled in the study. The treatment will be held in two arms. One arm will be administered only vaginal gel interferon treatment. The other arm will receive both vaginal gel interferon and rectal suppositories with interferon dosing 3,000,000 IU.
In the beginning of the study all patient will have cervical pap smear and HPV typing.
HPV testing will be done using real time PCR method to determine the subtype of HPV (16,18,31,33,35,39,45,51,52,56,59,68).
At the beginning and at the end of the study all patient will have histology test.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pap smear LSIL
- •HPV infection positive
- •No anti-viral treatment in 2 weeks before treatment
排除标准
- •No consent has obtained
- •Anti-viral treatment in 2 weeks
- •Breastfeeding or pregnant
研究组 & 干预措施
Control
Interferon α2b gel treatment for 30 days.
干预措施: gel Interferon arm (Drug)
Treatment
Interferon α2b gel treatment for 30 days
- Interferon α2b 3 MIU rectal suppository for 10 days
干预措施: gel Interferon arm (Drug)
Treatment
Interferon α2b gel treatment for 30 days
- Interferon α2b 3 MIU rectal suppository for 10 days
干预措施: gel Interferon and interferon suppository arm (Drug)
结局指标
主要结局
Pap smear
时间窗: 90 days
LSIL, HSIL or regression of the change will be assessed.
Colposcopic change
时间窗: 90 days
Cervical changes before and after treatment will be compared.
次要结局
- Histopathologic change(90 days)
- Immunohistochemical change(90 days)
研究者
Batsuren Choijamts
Head of department
Mongolian National University of Medical Sciences