Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers (MetLung)
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Met analysis on tissue and blood
Sponsored by
About this trial
This is an interventional basic science trial for Non Small Cell Lung Cancer focused on measuring Met fragments expression
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
Sites / Locations
- Centre Hospitalier Régional et Universitaire
- Oscar Lambret Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Met analysis
Arm Description
Met analysis on tissue and blood Western Blot Immunohistochemistry ELISA test
Outcomes
Primary Outcome Measures
Expression and localization of Met C-terminal active fragments in NSCLC
Western Blot and immunohistochemistry
Secondary Outcome Measures
Evaluation of the activation of Met receptor
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
Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival
Expression in plasma of N-terminal Met fragments
ELISA test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01647867
Brief Title
Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
Acronym
MetLung
Official Title
Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Met fragments expression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Met analysis
Arm Type
Experimental
Arm Description
Met analysis on tissue and blood Western Blot Immunohistochemistry ELISA test
Intervention Type
Other
Intervention Name(s)
Met analysis on tissue and blood
Intervention Description
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 Outcome Measure Information:
Title
Expression and localization of Met C-terminal active fragments in NSCLC
Description
Western Blot and immunohistochemistry
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Evaluation of the activation of Met receptor
Description
Activation of Met receptor by immunochemical analysis (Western Blot)
Time Frame
baseline
Title
Correlation between expression of Met receptor fragments with clinical characteristics and/or prognosis factors as sex, TNM, EGFR status, histology, smoking status, survival
Description
Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival
Time Frame
baseline
Title
Expression in plasma of N-terminal Met fragments
Description
ELISA test
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric DANSIN, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David TULASNE, PhD
Organizational Affiliation
Institute of Biology of Lille
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Régional et Universitaire
City
Lille
ZIP/Postal Code
59 037
Country
France
Facility Name
Oscar Lambret Center
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
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