Expression of Met Receptor Fragments in Non Small Cell Lung Cancer (MetLung)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Centre Oscar Lambret
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01647867
First received: July 17, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

Our project, established through collaboration between clinicians (COL-University Hospital) and scientists (IBL), aims to evaluate the expression of these fragments of Met 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 blotting of tumor samples and healthy tissue. This approach will evaluate the expression of full-length receptor, the presence potential intracellular fragments, and their phosphorylation level.


Condition Intervention
Non Small Cell Lung Cancer
Other: Met analysis on tissue and blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Expression of Met Receptor Fragments in Non Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Evaluate the expression of Met C-terminal active fragments in NSCLC [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Expression and localization of Met C-terminal active fragments in NSCLC(Western Blot and immunohistochemistry)


Secondary Outcome Measures:
  • Evaluate the activation of Met receptor [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Activation of Met receptor by immunochemical analysis (Western Blot)

  • Correlate expression of Met receptor fragments of the with clinical characteristics and/or prognosis factors as sex, TNM, EGFR status, histology, smoking status, survival [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival

  • Evaluate the expression in plasma of N-terminal Met fragments [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Expression in plasma of Met receptor N-terminal fragments (ELISA)


Estimated Enrollment: 55
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 what stage of the disease the patient is

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non small cell lung cancer (NSCLC)
  • Patients candidate for bronchial biopsies on Centre Oscar Lambret (metastatic stage) or candidate for thoracic surgery on CHRU de Lille (localized stage)
  • Chemo-naive for metastatic NSCLC
  • Patients with or without induction chemotherapy for localized NSCLC
  • Male or female subjects ≥ 18 years of age
  • Ability to understand and willingness to sign a written Informed Consent

Exclusion Criteria:

  • Non malignant tumors
  • Small-cell malignancies
  • Secondary malignant lesions
  • Previous cancer
  • Reversal surgery
  • Pregnant or breastfeeding women
  • Patient under guardianship
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647867

Contacts
Contact: Eric DANSIN, MD +33 (0)3.20.29.59.20 e-dansin@o-lambret.fr

Locations
France
Oscar Lambret Center Recruiting
Lille, France, 59020
Contact: Eric DANSIN, MD    +33 (0)3.20.29.59.20    e-dansin@o-lambret.fr   
Principal Investigator: Eric DANSIN, MD         
Centre Hospitalier Régional et Universitaire Not yet recruiting
Lille, France, 59 037
Contact: Henri PORTE, MDPhD    +33 (0)3.20.44.45.59    h-porte@chru-lille.fr   
Principal Investigator: Henri PORTE, MDPhD         
Sponsors and Collaborators
Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01647867     History of Changes
Other Study ID Numbers: MetLung - 1204
Study First Received: July 17, 2012
Last Updated: August 21, 2014
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Centre Oscar Lambret:
non small cell lung cancer
Met fragments

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

ClinicalTrials.gov processed this record on September 18, 2014