Pronostic and Predictive Value of EMT in Localized Lung Cancer (TWISTlung)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Helene Blons, PharmD PhD; Phone Number: 00 33 156095686; Email: helene.blons@aphp.fr
• Study Contact Backup: Name: Antoine Legras, MD PhD; Email: antoine.legras@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Aphp Hegp
    • Contact: Helene Blons, PharmD PhD; Phone Number: 00 33 156095686; Email: helene.blons@aphp.fr
    • Contact: Antoine Legras, MD PhD; Email: antoine.legras@aphp.fr
    • Principal Investigator: Francoise Lepimpec Barthes, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients treated by surgery at HEGP having signed the ONCOHEGP consent are eligible to this observational study

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NSCLC; NSCLC localized disease treated by surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse free survival	Time to relapse after surgery	1 year
Overall survival	Time to death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time to death	3 years

Collaborators and Investigators

• Sponsor: European Georges Pompidou Hospital
• Collaborators: APHP
• Investigators: Principal Investigator: Francoise Lepimpec Barthes, MD PhD, APHP

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2014
• Primary Completion (Actual): March 31, 2018
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 4, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: 2013-A01633-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No