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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03509779
Other study ID # 2013-A01633-42
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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