Overview

This trial is active, not recruiting.

Condition non small cell lung cancer
Treatment met analysis on tissue and blood
Target c-MET
Sponsor Centre Oscar Lambret
Start date July 2012
End date July 2015
Trial size 57 participants
Trial identifier NCT01647867, MetLung - 1204

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
Western Blot Immunohistochemistry ELISA test
met analysis on tissue and blood
10 mL of blood and 4 pieces of tissue (2 of tumor tissue, 2 of healthy tissue) all taken at the same time as surgery or bronchoscopy, depending on the stage of the disease

Primary Outcomes

Measure
Expression and localization of Met C-terminal active fragments in NSCLC
time frame: baseline

Secondary Outcomes

Measure
Evaluation of the activation of Met receptor
time frame: baseline
Correlation between expression of Met receptor fragments with clinical characteristics and/or prognosis factors as sex, TNM, EGFR status, histology, smoking status, survival
time frame: baseline
Expression in plasma of N-terminal Met fragments
time frame: baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.