Study of the Expression of Met Receptor Fragments in Non... | NCT01647867

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

NCT01647867

Sponsor

Centre Oscar Lambret

Status

Completed

Last Update Posted

Mar 13, 2026Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Non Small Cell Lung Cancer

Interventions

Met analysis on tissue and blood

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-A00468-35	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 27, 2012Actual

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 17, 2012

First Submission Date that Met QC Criteria

Jul 23, 2012

First Posted Date

Jul 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Met analysis	Experimental	Met analysis on tissue and blood Western Blot Immunohistochemistry ELISA test	Other: Met analysis on tissue and blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Met analysis on tissue and blood	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression and localization of Met C-terminal active fragments in NSCLC	Western Blot and immunohistochemistry	baseline

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the activation of Met receptor	Activation of Met receptor by immunochemical analysis (Western Blot)	baseline
Correlation between expression of Met receptor fragments with clinical characteristics and/or prognosis factors as sex, TNM, EGFR status, histology, smoking status, survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric DANSIN, MD	Centre Oscar Lambret	Study Director
David TULASNE, PhD	Institute of Biology of Lille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Régional et Universitaire		Lille		59 037	France
Oscar Lambret Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided