跳至主要内容
临床试验/NCT04753073
NCT04753073已完成不适用

Treatment of Cervical Intraepithelial Neoplasia (CIN) Grade III With Non-invasive Physical Plasma

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Rate of histological complete remission

研究概览

简要总结

The aim of the prospective, unicenter proof-of-principle study is to investigate the anti-neoplastic effectiveness of NIPP against CIN III lesions.

  • The aim of this project is to evaluate the potential of a previous NIPP treatment to significantly reduce the invasiveness of the LEEP excision.
  • Another aim of this study is to investigate cellular / molecular effects of NIPP following the in-vivo treatment of the cervix using molecular biological methods. For this purpose, tissue treated with plasma is taken after defined periods of time by mini biopsy and examined using molecular biological, histological and microscopic methods.

详细描述

Cervical intraepithelial neoplasms (CIN), classified into severity levels CIN I to III, can be precursors to cervical cancer (CC), the world's third most common cancer in women (270,000 deaths / year), which radical therapies are often associated with lifelong severe physical and emotional stress. Cross-sectional studies found a prevalence for CIN of 62 per 1,000 women and incidences of 1.2 (CIN I), 0.8 (CIN II) and 0.7 (CIN III) per 1,000 women per year (highest incidence of CIN between 20 and 24 years) age). The standard therapy for the treatment of CIN III by LEEP excision is associated with an increase in mortality of 17%. CIN III, in particular, is associated with a significant decline in quality of life, psychological well-being and sexual health, although on average only about 12% of CIN III lesions progress to invasive CC. The resulting over-treatment (in around 8-9 out of 10 patients) with invasive procedures is a serious problem for affected women, health care providers and the health economy.

The NIPP treatment is a tissue-sparing, pain-free, easy to carry out and outpatient treatment method without anesthesia and hospitalization. A non-randomized, one-arm feasibility study at the Department of Women's Health (649 / 2017BO1) already showed the effectiveness of a NIPP treatment.

Clinical implications for CIN III:

  • A previous NIPP treatment should significantly reduce the invasiveness of the LEEP excision.
  • If the oncological safety of NIPP treatment is comparable (histological complete remission of CIN III), NIPP is to be established as a safe alternative to LEEP excision in the future.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Histologically confirmed CIN III
  • Clearly visible transformation zone of the portio and margins of the lesions according to T1 / T2
  • signed written consent

排除标准

  • Not fully visible transformation zone
  • Indication of an invasive disease
  • Serious cardiovascular diseases
  • Patients who only want to undergo a LEEP excision

结局指标

主要结局

Rate of histological complete remission

时间窗: 8 Weeks

Rate of histological complete remission of the CIN III at the time of the LEEP excision

次要结局

  • Rate of partial histological remission(8 Weeks)
  • Rate of decreased HPV viral load(8 Weeks)
  • Pain and quality of life(8 Weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验