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

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ClinicalTrials.gov Identifier: NCT01647867
Recruitment Status : Unknown
Verified January 2016 by Centre Oscar Lambret.
Recruitment status was:  Active, not recruiting
First Posted : July 24, 2012
Last Update Posted : January 6, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Other: Met analysis on tissue and blood

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
Study Start Date : July 2012
Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Expression and localization of Met C-terminal active fragments in NSCLC [ Time Frame: baseline ]
    Western Blot and immunohistochemistry

Secondary Outcome Measures :
  1. Evaluation of the activation of Met receptor [ Time Frame: baseline ]
    Activation of Met receptor by immunochemical analysis (Western Blot)

  2. 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 ]
    Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival

  3. Expression in plasma of N-terminal Met fragments [ Time Frame: baseline ]
    ELISA test

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647867

Centre Hospitalier Régional et Universitaire
Lille, France, 59 037
Oscar Lambret Center
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
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
First Posted: July 24, 2012    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

Keywords provided by Centre Oscar Lambret:
Met fragments expression

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