Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT04677205
Status:
RECRUITING
Last Update Posted:
2023-01-09
First Post:
2020-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Signature From Tumor to Lymph Nodes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor DNA, Tumor RNA, cell free DNA from blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-06', 'studyFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2020-12-15', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease-free survival', 'timeFrame': '3 years', 'description': 'To identify a molecular signature based on a comprehensive molecular analysis at genomic and transcriptomic levels linked to 3-year disease-free survival in resected IIIA-N2 NSCLC.'}], 'secondaryOutcomes': [{'measure': '5-year disease-free survival', 'timeFrame': '5 years', 'description': 'To identify a molecular signature based on a comprehensive molecular analysis at genomic and transcriptomic levels linked to 5-year disease-free survival in resected IIIA-N2 NSCLC.'}, {'measure': 'pathological architectural patterns WHO 2015 classification', 'timeFrame': '5 years', 'description': 'To evaluate the impact of the pathological architectural patterns WHO 2015 classification on the 5-year cancer-specific survival and the 5-year overall survival'}, {'measure': 'anatomical lymphatic spread', 'timeFrame': 'at the end of molecular analyses', 'description': 'To identify tumor molecular patterns associated with specific anatomical lymphatic spread subgroups.'}, {'measure': 'ctDNA', 'timeFrame': '3 years', 'description': 'To assess ctDNA prognostic impact, before and after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'N2', 'molecular profile', 'prognosis'], 'conditions': ['Lung Cancer', 'Stage IIIA-cN2', 'Operated With Curative Intent', 'Primary Tumor Tissue Available', 'Node Tumor Tissue Available']}, 'referencesModule': {'references': [{'pmid': '22642691', 'type': 'BACKGROUND', 'citation': 'Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC Med. 2012 May 29;10:51. doi: 10.1186/1741-7015-10-51.'}, {'pmid': '24582052', 'type': 'BACKGROUND', 'citation': 'Legras A, Mordant P, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F, Riquet M. Long-term survival of patients with pN2 lung cancer according to the pattern of lymphatic spread. Ann Thorac Surg. 2014 Apr;97(4):1156-62. doi: 10.1016/j.athoracsur.2013.12.047. Epub 2014 Feb 26.'}, {'pmid': '23566374', 'type': 'BACKGROUND', 'citation': 'Lin IF, Chang WP, Liao YN. Shrinkage methods enhanced the accuracy of parameter estimation using Cox models with small number of events. J Clin Epidemiol. 2013 Jul;66(7):743-51. doi: 10.1016/j.jclinepi.2013.02.002. Epub 2013 Apr 6.'}, {'pmid': '27624137', 'type': 'BACKGROUND', 'citation': 'Pecuchet N, Rozenholc Y, Zonta E, Pietrasz D, Didelot A, Combe P, Gibault L, Bachet JB, Taly V, Fabre E, Blons H, Laurent-Puig P. Analysis of Base-Position Error Rate of Next-Generation Sequencing to Detect Tumor Mutations in Circulating DNA. Clin Chem. 2016 Nov;62(11):1492-1503. doi: 10.1373/clinchem.2016.258236. Epub 2016 Sep 13.'}, {'pmid': '8543964', 'type': 'BACKGROUND', 'citation': 'Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10. doi: 10.1016/0895-4356(95)00048-8.'}, {'pmid': '25907251', 'type': 'BACKGROUND', 'citation': 'Tapak L, Saidijam M, Sadeghifar M, Poorolajal J, Mahjub H. Competing risks data analysis with high-dimensional covariates: an application in bladder cancer. Genomics Proteomics Bioinformatics. 2015 Jun;13(3):169-76. doi: 10.1016/j.gpb.2015.04.001. Epub 2015 Apr 20.'}, {'pmid': '27634761', 'type': 'BACKGROUND', 'citation': 'Um SW, Joung JG, Lee H, Kim H, Kim KT, Park J, Hayes DN, Park WY. Molecular Evolution Patterns in Metastatic Lymph Nodes Reflect the Differential Treatment Response of Advanced Primary Lung Cancer. Cancer Res. 2016 Nov 15;76(22):6568-6576. doi: 10.1158/0008-5472.CAN-16-0873. Epub 2016 Sep 13.'}, {'pmid': '17182981', 'type': 'BACKGROUND', 'citation': 'Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'Mediastinal lymph node (LN) involvement (N2) in non-small cell lung cancer (NSCLC) concerns 15% of resectable tumors and is associated with a poor prognosis and an overall survival reaching 9 to 49%. Literature fails to provide any definitive consensus regarding the management of these patients, except for the platinum-based doublet chemotherapy. The N2 involvement remains a matter of debate because of its not yet well-classified heterogeneity. Regarding anatomy, the Mountain and Dresler\'s regional LN classification for lung cancer staging remains the reference. Different studies classified IIIA-N2 disease into 4 groups, in addition to the skip-N2 phenomenon: minimal-N2, N2 single station, N2 multiple stations, and bulky-N2. Other subgroups were recently proposed for the 8th edition of the TNM: N2a1 - single station skip, N2a2 - single station non-skip, N2b - multiple stations.\n\nThe French National Cancer Institute (INCa) proposed guidelines, but in case of cN2 staging without mediastinal infiltration, guidelines remained imprecise ("resectability should be discussed for each case") and suggested surgery first, or induction chemotherapy, or concomitant chemoradiation.\n\nThus, optimal management of cIIIA-N2 remains controversial but complete tumor resection can be related to long-term survival in some patients, including 10 years after surgery \\[1\\]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.', 'detailedDescription': 'We planned a comprehensive molecular characterization of tumors and lymph nodes to evaluate the impact of molecular signatures and molecular heterogeneity on disease-free survival after surgery in IIIA-N2 NSCLC patients. Identification of specific molecular profiles in primary tumors and evolution profiles in nodes might provide clues to the potential risk of metastatic evolution and trigger specific management.\n\nFor patients included prospectively, we planned to analyze cell free circulating tumor DNA (ctDNA) as prognostic marker. Because multiple biopsies are not always available in care settings, ctDNA could also be analyzed as a surrogate marker of molecular heterogeneity. Next generation sequencing (NGS) that was validated in our lab to screen ctDNA using a specific bio-informatics workflow allows accurate and cost effective ctDNA screening'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '230 patients in 11 French centers in order to have 200 eligible patients. Objectives are 120 patients recruited retrospectively and 110 prospectively.\n\nInclusion criteria are: all consecutive patients operated with a curative intent for an IIIA-cN2 NSCLC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, men and women age \\>18 years\n* Patients operated with a curative intent for an IIIA-cN2 NSCLC\n* Social security affiliation\n* Written informed consent for patient included in part 2 (prospective) or not opposing the use of this data for patient included in part 1 (retrospective)\n\nExclusion Criteria:\n\n* Patient with T4, R1 or R2 surgical resection, sublobar resection, no radical lymphadenectomy\n* Patient under protectives measures\n* Pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT04677205', 'acronym': 'N2-3S', 'briefTitle': 'Molecular Signature From Tumor to Lymph Nodes', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?', 'orgStudyIdInfo': {'id': 'D20180155'}, 'secondaryIdInfos': [{'id': 'D20180155', 'type': 'OTHER', 'domain': 'Assistance Publique - Hôpitaux de Paris'}, {'id': '2019-A02635-52', 'type': 'OTHER', 'domain': 'N° IDRCB'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques JOUGON, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital du Haut-Lévêque, CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clamart', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand GRAND, Dr', 'role': 'CONTACT'}], 'facility': 'Hôpital Militaire Percy', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pascal THOMAS, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nice', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérome MOUROUX, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Pasteur, CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75015', 'city': 'Paris', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Hegp-Aphp', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Françoise LE PIMPEC-BARTHES, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Européen Georges-Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Pierre MORDANT, Dr', 'role': 'CONTACT'}], 'facility': 'Hôpital Bichat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marco ALIFANO, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bertrand RICHARD DE LA TOUR, PR', 'role': 'CONTACT'}], 'facility': 'Hôpital Pontchaillou, CHU de Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'MASSARD Gilbert, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpitaux universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent BROUCHET, Pr', 'role': 'CONTACT'}], 'facility': 'Hôpital Larrey, CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Antoine LEGRAS, Dr', 'role': 'CONTACT'}], 'facility': 'CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Antoine LEGRAS, MD PhD', 'role': 'CONTACT', 'email': 'antlegras@gmail.com', 'phone': '33 2 47474747'}, {'name': 'Liliane HAMMANI-BERKANI, MSc', 'role': 'CONTACT', 'email': 'liliane.berkani@aphp.fr', 'phone': '33 156093762'}], 'overallOfficials': [{'name': 'Helene BLONS, PharmD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Européen Georges-Pompidou'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Two years after the last publication', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.', 'accessCriteria': 'Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.\n\nTeams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'Université de Paris', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}