Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-08 @ 11:08 PM
Study NCT ID:
NCT01647867
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2012-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression and localization of Met C-terminal active fragments in NSCLC', 'timeFrame': 'baseline', 'description': 'Western Blot and immunohistochemistry'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the activation of Met receptor', 'timeFrame': 'baseline', 'description': 'Activation of Met receptor by immunochemical analysis (Western Blot)'}, {'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', 'description': 'Relationships between Met receptor expression and sex, TNM, EGFR status, histology, smoking status, survival'}, {'measure': 'Expression in plasma of N-terminal Met fragments', 'timeFrame': 'baseline', 'description': 'ELISA test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Met fragments expression'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '* Patient information and collection of signed inform consent\n* Blood sample collection before bronchoscopy or before surgery, at the same time as a usual blood assessment.\n* Prospective collection of bronchial biopsies of patients with metastatic non small cell lung cancer, during a bronchoscopy at the Oscar Lambret Center (Dr Dansin)\n* 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)\n* Transportation of the samples to the pathology laboratories (Dr Robin, Pr Copin)\n* Selection of blocks of interest and preparation of tumor samples\n* Clinical data collection : date of biopsy or surgery, disease-free survival, overall survival, tumor characteristics, EGFR status, ALK, BRAF, HER2\n* Transportation of tumor blocks and blood samples to the Institute of Biology of Lille for analyses: Western blot, immunohistochemistry and ELISA test)\n* Return to storage of the tumor samples at the Oscar Lambret Center and at the University hospital of Lille'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with non small cell lung cancer (NSCLC)\n* Patients candidate for bronchial biopsies at the Oscar Lambret Center (metastatic stage) or candidate for thoracic surgery at University Hospital of Lille (localized stage)\n* Treatment naive patient for metastatic NSCLC\n* Patients with or without neoadjuvant therapy for localized NSCLC\n* Male or female patients aged ≥ 18 years\n* Patient registered with the social security system\n* Having signed a written Informed Consent\n\nExclusion Criteria:\n\n* Malignant tumors which are not carcinoma\n* Small-cell malignant tumors\n* Secondary bronchial lesions\n* Revision surgery\n* Pregnant or breastfeeding women\n* Patient under guardianship or tutorship\n* Previous cancer'}, 'identificationModule': {'nctId': 'NCT01647867', 'acronym': 'MetLung', 'briefTitle': 'Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Study of the Expression of Met Receptor Fragments in Non Small Cell Lung Cancers', 'orgStudyIdInfo': {'id': 'MetLung - 1204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Met analysis', 'description': 'Met analysis on tissue and blood Western Blot Immunohistochemistry ELISA test', 'interventionNames': ['Other: Met analysis on tissue and blood']}], 'interventions': [{'name': 'Met analysis on tissue and blood', 'type': 'OTHER', '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', 'armGroupLabels': ['Met analysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59 037', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Hospitalier Régional et Universitaire', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Oscar Lambret Center', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Eric DANSIN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Oscar Lambret'}, {'name': 'David TULASNE, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Biology of Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}