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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
Centre Oscar Lambret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Non Small Cell Lung Cancer focused on measuring Met fragments expression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 17, 2012
Last Updated
March 21, 2018
Sponsor
Centre Oscar Lambret
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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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