Pronostic and Predictive Value of EMT in Localized Lung Cancer

Surgery Clinical Trial

— TWISTlung  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03509779
• Other study ID #: 2013-A01633-42
• Status: Recruiting
• Start date: October 20, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2018
• Source: European Georges Pompidou Hospital
• Contact: Helene BLONS, PharmD PhD
• Phone: 00 33 156095686
• Email: helene.blons[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Aphp Hegp	Paris

Sponsors (2)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital	APHP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse free survival	Time to relapse after surgery	1 year
Primary	Overall survival	Time to death	5 years
Secondary	Overall survival	Time to death	3 years