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临床试验/NCT03935802
NCT03935802已完成不适用

Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy

University of Jena1 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2002年9月1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
161
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.

详细描述

In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • histologically confirmed invasive breast carcinoma
  • age >= 18 years
  • exclusive treatment at the Jena University Hospital
  • complete curative-intended adjuvant or definite radiotherapy
  • at least 2 blood collections (before the start of therapy, after the end of the RT)

排除标准

  • presence of metastases
  • recurrence
  • DCIS, inflammatory breast cancer
  • second malignancy <10 years before diagnosis of breast cancer
  • radiotherapeutic pretreatment

结局指标

主要结局

Overall survival

时间窗: up to 10 years

from the start of Radiotherapy until death / last seen during follow up

次要结局

  • Disease free survival(up to 10 years)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthias Mäurer

Dr. Matthias Mäurer

University of Jena

研究点 (1)

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