Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT00213733
Status:
COMPLETED
Last Update Posted:
2011-08-30
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Assessment of Lymph Nodes in Patients With Resected (Stage I to IIIA) Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-29', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Lung cancer patients', 'non-small cell lung cancer', 'molecular marker', 'lymph node completed resected', 'Lung cancer samples and paired lymph node resected'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective study of surgically resected samples and lymph nodes of lung cancer patients. For histopathologically positive lymph nodes from a complete resection, the investigators would like to analyse tumor tissue by allelotyping and comparing these results with those observed in the primary lung tumor to establish a cartography of molecular alteration in resected lung cancer. For non histopathologically positive lymph nodes, the investigators would like to research the presence (or not) of micrometastasis by allele-specific PCR (polymerase chain reaction).', 'detailedDescription': 'Genetic: It is a prospective study during two years with three years for follow-up. No control group is recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with resectable non-small cell lung cancer (stage I to IIIA), with a complete resection of the tumor and paired lymph nodes.\n* Informed consent is required.\n\nExclusion Criteria:\n\n* Another cancer\n* Chemotherapy before surgical treatment'}, 'identificationModule': {'nctId': 'NCT00213733', 'briefTitle': 'Molecular Assessment of Lymph Nodes in Patients With Resected (Stage I to IIIA) Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Research of Molecular Markers for Diagnosis and/or Prognosis in Lymph Node Metastasis of Resected Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '3207'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Thoracique, Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Pneumologie, Hôpital Lyautey', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': "Service d'Anatomie Pathologique, Hôpital de Hautepierre", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Pneumologie, Hôpital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Michèle BEAU-FALLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratoire de Biochimie et de Biologie Moléculaire, Hôpital de Hautepierre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Emmanuel LAVOUE, Directeur Adjoint de la DRCI', 'oldOrganization': 'University Hospital, Strasbourg, France'}}}}