Clinical trial NCT01647867: Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
Official title: Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: Met fragments expression
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

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

Primary outcomes:
measure: Expression and localization of Met C-terminal active fragments in NSCLC
timeFrame: baseline
Secondary outcomes:
measure: Evaluation of the activation of Met receptor
timeFrame: baseline
measure: Correlation between expression of Met receptor fragments with clinical characteristics and/or prognosis factors as sex, TNM, EGFR status, histology, smoking status, survival
timeFrame: baseline
measure: Expression in plasma of N-terminal Met fragments
timeFrame: baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Hospitalier Régional et Universitaire
city: Lille
country: France
facility: Oscar Lambret Center
Study officials:
affiliation: Centre Oscar Lambret
name: Eric DANSIN, MD
role: STUDY_DIRECTOR
affiliation: Institute of Biology of Lille
name: David TULASNE, PhD
role: STUDY_DIRECTOR
References: