Molecular Signature From Tumor to Lymph Nodes (N2-3S)
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|ClinicalTrials.gov Identifier: NCT04677205|
Recruitment Status : Not yet recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
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.
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 . In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.
|Condition or disease|
|Lung Cancer Stage IIIA-cN2 Operated With Curative Intent Primary Tumor Tissue Available Node Tumor Tissue Available|
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.
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
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2027|
- 3-year disease-free survival [ Time Frame: 3 years ]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.
- 5-year disease-free survival [ Time Frame: 5 years ]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.
- pathological architectural patterns WHO 2015 classification [ Time Frame: 5 years ]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
- anatomical lymphatic spread [ Time Frame: at the end of molecular analyses ]To identify tumor molecular patterns associated with specific anatomical lymphatic spread subgroups.
- ctDNA [ Time Frame: 3 years ]To assess ctDNA prognostic impact, before and after surgery.
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677205
|Contact: Antoine LEGRAS, MD PhD||33 2 firstname.lastname@example.org|
|Contact: Liliane HAMMANI-BERKANI, MSc||33 email@example.com|
|Hôpital du Haut-Lévêque, CHU de Bordeaux|
|Contact: Jacques JOUGON, Pr|
|Hôpital Militaire Percy|
|Contact: Pascal THOMAS, Pr|
|Hôpital Pasteur, CHU de Nice|
|Paris, France, 75015|
|Hôpital Européen Georges-Pompidou|
|Paris, France, 75015|
|Contact: Françoise LE PIMPEC-BARTHES, Pr|
|Contact: Marco ALIFANO, Pr|
|Hôpital Pontchaillou, CHU de Rennes|
|Hôpitaux universitaires de Strasbourg|
|Contact: MASSARD Gilbert, Pr|
|Hôpital Larrey, CHU de Toulouse|
|Contact: Laurent BROUCHET, Pr|
|CHRU de Tours|
|Principal Investigator:||Helene BLONS, PharmD PhD||Hôpital Européen Georges-Pompidou|