Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast
研究概览
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
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Brussels、比利时、1200
- 招聘中
- Cliniques Universitaires Saint-Luc
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接触:
- François DUHOUX, MD,PhD
- 电话号码:0032 2 764
- 邮箱:francois.duhoux@uclouvain.be
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women and men with breast cancer
- Treated with neoadjuvant chemotherapy
Exclusion Criteria:
- None
学习计划
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 |
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其他:Retrospective study
Tumoral tissue of 100 patients with breast cancer treated with neoadjuvant chemotherapy.
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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.
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其他:Prospective study
Tumoral tissue and plasma of 120 patients with breast cancer treated with neoadjuvant chemotherapy.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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
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an average of 2 years
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合作者和调查者
调查人员
- 首席研究员:François DUHOUX, MD, PhD、francois.duhoux@uclouvain.be
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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