Pronostic and Predictive Value of EMT in Localized Lung Cancer

Recruiting

• Conditions: Surgery; NSCLC, Stage I, II, IIIA, IIIB; Progression; Epithelial Mesenchymal Transition

• Registration Number: NCT03509779
• Lead Sponsor: European Georges Pompidou Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-10-20
• Primary Completion: 2018-03-31
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-26
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• Informed consent ONCOHEGP not signed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse free survival	1 year	Time to relapse after surgery
Overall survival	5 years	Time to death

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	Time to death

Trial Locations

Locations (1)

Aphp Hegp; 🇫🇷 Paris, France