跳至主要内容
临床试验/NCT03509779
NCT03509779招募中不适用

EMT, Reactivation of Embryonic Transcription Factors and Alteration of the miR Signaling Network as Pronostic and Predictive Markers in Lung Cancer

European Georges Pompidou Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2014年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Relapse free survival

研究概览

简要总结

The goal of the present research is to identify an "EMT signature", associated with long term disease-free survival after surgery in NSCLC. This study will potentially lead to specific treatment recommendations, thanks to an integrated molecular approach including DNA, RNA and miR profiling In vitro analyses using lung cancer cell lines will subsequently be conducted to validate markers identified in tumor screenings.

详细描述

One critical issue in studying oncogenesis is the comprehensive understanding of tumor genome complexity. Molecular subtypes may be identified through large-scale molecular screenings or gene expression analyses and molecular signatures are recognized as a relevant source of disease stratification.

The investigators will focus on NSCLC patients with localized diseases included in the ONCOHEGP tissue collection project (OncoHEGP, Ministere de la Recherche n° DC 2009-950). The investigators had previously shown that in EGFR mutated cancer, reactivation of TWIST1 was reversibly linked to EMT and to survival. To go further, the investigators plane to investigate EMT in a large cohort of patients with lung cancer to identify prognostic and predictive markers of long term survival.

The investigators will integrate mutation, and copy number alterations to EMT gene expression analyses and to EMT related miR quantification. Tumor phenotype, miR signatures, mutation status will help classify patients according to survival.

Clinical data will be assessed thanks to the epithor database. Epithor is a government-recognized clinical database, accredited by the French Health Authorities (Haute Autorité de Santé) and is supported by the National Cancer Institute (Institut National du Cancer).

EMT characterization and scoring will be done using 10 markers by qPCR, mutation and CNV screenings by targeted NGS analysis, miRs signature by MIRSeq and qPCR.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with NSCLC stage I II IIIA IIIB, treated by surgery at Georges Pompidou Hospital (HEGP) Informed consent ONCOHEGP signed

排除标准

  • Informed consent ONCOHEGP not signed

结局指标

主要结局

Relapse free survival

时间窗: 1 year

Time to relapse after surgery

Overall survival

时间窗: 5 years

Time to death

次要结局

  • Overall survival(3 years)

研究者

发起方
European Georges Pompidou Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hélène Blons

Professor

European Georges Pompidou Hospital

研究点 (1)

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