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

NCT ID: NCT01647867

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-07-31

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

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Met analysis

Met analysis on tissue and blood Western Blot Immunohistochemistry ELISA test

Group Type: EXPERIMENTAL

Met analysis on tissue and blood

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric DANSIN, MD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

David TULASNE, PhD

Role: STUDY_DIRECTOR

Institute of Biology of Lille

Locations

Centre Hospitalier Régional et Universitaire

Lille, , France

Oscar Lambret Center

Lille, , France

Countries

France

Other Identifiers

MetLung - 1204

Identifier Type: -

Identifier Source: org_study_id