Pronostic and Predictive Value of EMT in Localized Lung Cancer

NCT ID: NCT03509779

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-20

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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NSCLC, Stage I, II, IIIA, IIIB Surgery Progression Epithelial Mesenchymal Transition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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NSCLC

NSCLC localized disease treated by surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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APHP

OTHER

Sponsor Role collaborator

European Georges Pompidou Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hélène Blons

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francoise Lepimpec Barthes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Aphp Hegp

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Helene BLONS, PharmD PhD

Role: CONTACT

00 33 156095686

Antoine Legras, MD PhD

Role: CONTACT

Facility Contacts

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Helene Blons, PharmD PhD

Role: primary

00 33 156095686

Antoine Legras, MD PhD

Role: backup

References

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Garinet S, Didelot A, Marisa L, Beinse G, Sroussi M, Le Pimpec-Barthes F, Fabre E, Gibault L, Laurent-Puig P, Mouillet-Richard S, Legras A, Blons H. A novel Chr1-miR-200 driven whole transcriptome signature shapes tumor immune microenvironment and predicts relapse in early-stage lung adenocarcinoma. J Transl Med. 2023 May 15;21(1):324. doi: 10.1186/s12967-023-04086-7.

Reference Type DERIVED
PMID: 37189151 (View on PubMed)

Other Identifiers

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2013-A01633-42

Identifier Type: -

Identifier Source: org_study_id

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