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

Non Small Cell Lung Cancer Clinical Trial

— MetLung  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647867
• Other study ID #: MetLung - 1204
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: March 21, 2018
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Régional et Universitaire	Lille
France	Oscar Lambret Center	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Centre Oscar Lambret

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression and localization of Met C-terminal active fragments in NSCLC	Western Blot and immunohistochemistry	baseline
Secondary	Evaluation of the activation of Met receptor	Activation of Met receptor by immunochemical analysis (Western Blot)	baseline
Secondary	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	baseline
Secondary	Expression in plasma of N-terminal Met fragments	ELISA test	baseline