Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-03-30
2027-11-30
Brief Summary
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The 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.
Thus, 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.
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Detailed Description
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For 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
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* Patients operated with a curative intent for an IIIA-cN2 NSCLC
* Social security affiliation
* 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)
Exclusion Criteria
* Patient under protectives measures
* Pregnancy or breast-feeding
18 Years
ALL
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Ministry of Health, France
OTHER_GOV
Université de Paris
UNKNOWN
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Helene BLONS, PharmD PhD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Européen Georges-Pompidou
Locations
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Hôpital du Haut-Lévêque, CHU de Bordeaux
Bordeaux, , France
Hôpital Militaire Percy
Clamart, , France
Hôpital Nord
Marseille, , France
Hôpital Pasteur, CHU de Nice
Nice, , France
Hegp-Aphp
Paris, , France
Hôpital Européen Georges-Pompidou
Paris, , France
Hôpital Bichat
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Pontchaillou, CHU de Rennes
Rennes, , France
Hôpitaux universitaires de Strasbourg
Strasbourg, , France
Hôpital Larrey, CHU de Toulouse
Toulouse, , France
CHRU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Jacques JOUGON, Pr
Role: primary
Bertrand GRAND, Dr
Role: primary
Pascal THOMAS, Pr
Role: primary
Jérome MOUROUX, Pr
Role: primary
Françoise LE PIMPEC-BARTHES, Pr
Role: primary
Pierre MORDANT, Dr
Role: primary
Marco ALIFANO, Pr
Role: primary
Bertrand RICHARD DE LA TOUR, PR
Role: primary
MASSARD Gilbert, Pr
Role: primary
Laurent BROUCHET, Pr
Role: primary
Antoine LEGRAS, Dr
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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D20180155
Identifier Type: OTHER
Identifier Source: secondary_id
2019-A02635-52
Identifier Type: OTHER
Identifier Source: secondary_id
D20180155
Identifier Type: -
Identifier Source: org_study_id
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