- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03314870
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast Cancer (Breast-sign)
Development of a Response Signature to Neoadjuvant Chemotherapy for Breast
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Brussels, 벨기에, 1200
- 모병
- Cliniques Universitaires Saint-luc
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연락하다:
- François DUHOUX, MD,PhD
- 전화번호: 0032 2 764
- 이메일: francois.duhoux@uclouvain.be
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women and men with breast cancer
- Treated with neoadjuvant chemotherapy
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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.
기간: an average of 2 years
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an average of 2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: François DUHOUX, MD, PhD, francois.duhoux@uclouvain.be
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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