Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers

Not Applicable

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Other: Met analysis on tissue and blood

• Registration Number: NCT01647867
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

Our project, established through collaboration between clinicians (Oscar Lambret Center-University Hospital) and scientists (IBL), aims to evaluate the expression of Met fragments in the lung cancer (LC). Unlike previous studies on Met by sequencing, in situ hybridization or immunohistochemistry, the investigators propose a protein analysis by Western blot of tumor samples and healthy tissue. This approach will evaluate the expression of full-length receptor, the potential presence of intracellular fragments, and their phosphorylation status.

Detailed Description

* Patient information and collection of signed inform consent

* Blood sample collection before bronchoscopy or before surgery, at the same time as a usual blood assessment.

* Prospective collection of bronchial biopsies of patients with metastatic non small cell lung cancer, during a bronchoscopy at the Oscar Lambret Center (Dr Dansin)

* Prospective collection of resected specimens of patients with localized non small cell lung cancer, who were operated at the thoracic surgery unit of the University hospital (Pr Porte)

* Transportation of the samples to the pathology laboratories (Dr Robin, Pr Copin)

* Selection of blocks of interest and preparation of tumor samples

* Clinical data collection : date of biopsy or surgery, disease-free survival, overall survival, tumor characteristics, EGFR status, ALK, BRAF, HER2

* Transportation of tumor blocks and blood samples to the Institute of Biology of Lille for analyses: Western blot, immunohistochemistry and ELISA test)

* Return to storage of the tumor samples at the Oscar Lambret Center and at the University hospital of Lille

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Primary Completion: 2015-07
• Study Completion: 2016-07
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Patients with non small cell lung cancer (NSCLC)
• Patients candidate for bronchial biopsies at the Oscar Lambret Center (metastatic stage) or candidate for thoracic surgery at University Hospital of Lille (localized stage)
• Treatment naive patient for metastatic NSCLC
• Patients with or without neoadjuvant therapy for localized NSCLC
• Male or female patients aged ≥ 18 years
• Patient registered with the social security system
• Having signed a written Informed Consent

Exclusion Criteria

• Malignant tumors which are not carcinoma
• Small-cell malignant tumors
• Secondary bronchial lesions
• Revision surgery
• Pregnant or breastfeeding women
• Patient under guardianship or tutorship
• Previous cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Met analysis	Met analysis on tissue and blood	Met analysis on tissue and blood Western Blot Immunohistochemistry ELISA test

Primary Outcome Measures

Name	Time	Method
Expression and localization of Met C-terminal active fragments in NSCLC	baseline	Western Blot and immunohistochemistry

Secondary Outcome Measures

Name	Time	Method
Expression in plasma of N-terminal Met fragments	baseline	ELISA test
Correlation between expression of Met receptor fragments with clinical characteristics and/or prognosis factors as sex, TNM, EGFR status, histology, smoking status, survival	baseline	Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival
Evaluation of the activation of Met receptor	baseline	Activation of Met receptor by immunochemical analysis (Western Blot)

Trial Locations

Locations (2)

Oscar Lambret Center; 🇫🇷 Lille, France

Centre Hospitalier Régional et Universitaire; 🇫🇷 Lille, France