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Spots Global Cancer Trial Database for Molecular Signature From Tumor to Lymph Nodes

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Trial Identification

Brief Title: Molecular Signature From Tumor to Lymph Nodes

Official Title: Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?

Study ID: NCT04677205

Interventions

Study Description

Brief Summary: 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 \[1\]. In this situation, the identification of markers that will help select IIIA-N2 patients who will benefit from surgical resection is mandatory.

Detailed Description: 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H么pital du Haut-L茅v锚que, CHU de Bordeaux, Bordeaux, , France

H么pital Militaire Percy, Clamart, , France

H么pital Nord, Marseille, , France

H么pital Pasteur, CHU de Nice, Nice, , France

Hegp-Aphp, Paris, , France

H么pital Europ茅en Georges-Pompidou, Paris, , France

H么pital Bichat, Paris, , France

H么pital Cochin, Paris, , France

H么pital Pontchaillou, CHU de Rennes, Rennes, , France

H么pitaux universitaires de Strasbourg, Strasbourg, , France

H么pital Larrey, CHU de Toulouse, Toulouse, , France

CHRU de Tours, Tours, , France

Contact Details

Name: Helene BLONS, PharmD PhD

Affiliation: H么pital Europ茅en Georges-Pompidou

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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