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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647867
First received: July 17, 2012
Last updated: January 5, 2016
Last verified: January 2016
  Purpose
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.

Condition Intervention
Non Small Cell Lung Cancer
Other: Met analysis on tissue and blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Expression and localization of Met C-terminal active fragments in NSCLC [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Western Blot and immunohistochemistry


Secondary Outcome Measures:
  • Evaluation of the activation of Met receptor [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Activation of Met receptor by immunochemical analysis (Western Blot)

  • 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 ] [ Designated as safety issue: No ]
    Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival

  • Expression in plasma of N-terminal Met fragments [ Time Frame: baseline ] [ Designated as safety issue: No ]
    ELISA test


Estimated Enrollment: 57
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Met analysis
Western Blot Immunohistochemistry ELISA test
Other: 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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647867

Locations
France
Centre Hospitalier Régional et Universitaire
Lille, France, 59 037
Oscar Lambret Center
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Eric DANSIN, MD Centre Oscar Lambret
Study Director: David TULASNE, PhD Institute of Biology of Lille
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01647867     History of Changes
Other Study ID Numbers: MetLung - 1204 
Study First Received: July 17, 2012
Last Updated: January 5, 2016
Health Authority: France: Committee for the Protection of Personnes
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Oscar Lambret:
Met fragments expression

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on May 03, 2016