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Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)

Development of a Response Signature to Neoadjuvant Chemotherapy for Breast

Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant chemotherapy, administered before surgical resection. Unfortunately, many patients do not respond to this treatment, or only respond partially. Clinicians therefore need predictive biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.

研究概览

地位

未知

条件

详细说明

Breast cancer is the most frequent cancer in women. It is often treated with neoadjuvant chemotherapy, administered before surgical resection. Unfortunately, many patients do not respond to this treatment, or only respond partially. Clinicians therefore need predictive biomarkers of treatment response. Thanks to an innovative technique, called CATS, this study aims at identifying blood and tissue biomarkers which are predictive of response to chemotherapy.

The objective of this study is to develop molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition (EMT) status and their immune status. As these two parameters are known to be responsible for incomplete responses to chemotherapy, investigators hypothesize that these signatures will be predictive of response to neoadjuvant chemotherapy. In a second step, researchers will evaluate the ability of these signatures to predict treatment response in breast cancer patients treated with neoadjuvant chemotherapy.

The investigators will investigate two types of signatures: a tissue signature and a circulating signature. The former is based on the level of expression of several mRNA and miRNA assessed by CATS-RNASeq in the biopsy. The circulating signature will be based on the expression level of several miRNA by the same technique. Given that the expression level of tumoral miRNA is affected by the EMT and immunological status, and given that tumors secrete miRNA in the circulation, investigators expect the miRNA plasma content to reflect the EMT and immunological status of the tumor. The circulating signature will have the additional advantage of being independent of tumor heterogeneity.

研究类型

介入性

注册 (预期的)

220

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Women and men with breast cancer
  • Treated with neoadjuvant chemotherapy

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Retrospective study
Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.
To identify molecular signatures of EMT / immune status by using the random forest algorithm. The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.
其他:Prospective study
Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.
To identify molecular signatures of EMT / immune status by using the random forest algorithm. The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The number of molecular signatures predictive of response to neoadjuvant chemotherapy which would be able to discriminate between patient groups based on their epithelio-mesenchymal transition status and their immune status.
大体时间:an average of 2 years
an average of 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:François DUHOUX, MD, PhD、francois.duhoux@uclouvain.be

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年8月7日

初级完成 (预期的)

2019年12月31日

研究完成 (预期的)

2019年12月31日

研究注册日期

首次提交

2017年9月23日

首先提交符合 QC 标准的

2017年10月18日

首次发布 (实际的)

2017年10月19日

研究记录更新

最后更新发布 (实际的)

2019年7月15日

上次提交的符合 QC 标准的更新

2019年7月12日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2017/25JUL/376

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

There is no IPD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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