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TWISTlung: Pronostic and Predictive Value of EMT in Localized Lung Cancer

Sponsor
European Georges Pompidou Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03509779
Collaborator
APHP (Other)
1,000
Enrollment
1
Location
134.4
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    EMT, Reactivation of Embryonic Transcription Factors and Alteration of the miR Signaling Network as Pronostic and Predictive Markers in Lung Cancer
    Actual Study Start Date :
    Oct 20, 2014
    Actual Primary Completion Date :
    Mar 31, 2018
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    NSCLC

    NSCLC localized disease treated by surgery

    Outcome Measures

    Primary Outcome Measures

    1. Relapse free survival [1 year]

      Time to relapse after surgery

    2. Overall survival [5 years]

      Time to death

    Secondary Outcome Measures

    1. Overall survival [3 years]

      Time to death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aphp Hegp Paris France 75015

    Sponsors and Collaborators

    • European Georges Pompidou Hospital
    • APHP

    Investigators

    • Principal Investigator: Francoise Lepimpec Barthes, MD PhD, APHP

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hélène Blons, Professor, European Georges Pompidou Hospital
    ClinicalTrials.gov Identifier:
    NCT03509779
    Other Study ID Numbers:
    • 2013-A01633-42
    First Posted:
    Apr 26, 2018
    Last Update Posted:
    Sep 6, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Disease Progression

    Study Results

    No Results Posted as of Sep 6, 2018