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临床试验/NCT03436251
NCT03436251已完成不适用

Evaluation of Local Hyperthermia for the Treatment of Cervical Intraepithelial Neoplasias After 3 Months: a Multicenter, Single-blind, Randomized Controlled Trial

First Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2018年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
clearance rates of HPV

研究概览

简要总结

Human papillomavirus(HPV) infect epithelial cells and have the capacity to stimulate cell abnormal hyperplasia, especially by those high-risk HPV types. HPV vaccine primarily targeting HPV6/11/16/18 has been available and makes it possible to prevent cervical cancer. However, a large population was left unvaccinated, specifically for those aged ones. In clinic, patients harboring high-risk HPV is quite prevalent in China or other developing nations. Removing the virus and prevention of malignant transformation is required.

Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions.

详细描述

Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of cervical intraepithelial neoplasias grade I and II after 3 months, with positive high-risk type HPVs, and patients with positive testing for high risk HPVs. Appropriate control arms were designed for different conditions. One control arm is local hyperthermia at 37°C for 30 mins targeted for CINⅠ, the other control arm is LEEP targeted for CINⅡ. After 3 months, to evaluate the effectivity of local hyperthermia.

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

入选标准

  • 18-65 years old; generally healthy gynecological conditions, normal sexual life; high risk HPV; Cervical biopsy CIN or no cytological changes; signed informed consent

排除标准

  • Pregnant woman;local or systematic treatment within 3 months; Comorbidity of other severe gynecological inflammation, infection, or tumor; Comorbidity of other serious illnesses; no guarantee of timely treatment and follow-up

结局指标

主要结局

clearance rates of HPV

时间窗: 3 months after the last time of treatment.

to evaluate the clearance rates in different treatment groups 3 month after treatment.

scoring atypia by cytology/pathology

时间窗: 3 months after the last time of treatment.

to evaluate atypia severity score of cervical cells 3 month after treatment.

次要结局

  • viral load measurement(3 months after the last time of treatment.)

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Xinghua

professor

First Hospital of China Medical University

研究点 (1)

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