Clinical trial NCT03509779: Pronostic and Predictive Value of EMT in Localized Lung Cancer
Official title: EMT, Reactivation of Embryonic Transcription Factors and Alteration of the miR Signaling Network as Pronostic and Predictive Markers in Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC, Stage I, II, IIIA, IIIB
Surgery
Progression
Epithelial Mesenchymal Transition
Lead sponsor: European Georges Pompidou Hospital
Sponsor class: OTHER
Collaborators: name: APHP
First posted: 2018-04-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Aphp Hegp
Study officials:
affiliation: APHP
name: Francoise Lepimpec Barthes, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: