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Clinical Trials in France / NCT04677205
Recruiting Observational

Molecular Signature From Tumor to Lymph Nodes

NCT04677205 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-03-30
Last updated
2023-01-09

Condition(s) studied

Lung CancerStage IIIA-cN2Operated With Curative IntentPrimary Tumor Tissue AvailableNode Tumor Tissue Available

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patient, men and women age \>18 years * 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 with T4, R1 or R2 surgical resection, sublobar resection, no radical lymphadenectomy * Patient under protectives measures * Pregnancy or breast-feeding

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Hôpital du Haut-Lévêque, CHU de Bordeaux Bordeaux France Not Yet Recruiting
Hôpital Militaire Percy Clamart France Not Yet Recruiting
Hôpital Nord Marseille France Not Yet Recruiting
Hôpital Pasteur, CHU de Nice Nice France Not Yet Recruiting
Hegp-Aphp Paris France Active Not Recruiting
Hôpital Européen Georges-Pompidou Paris France Recruiting
Hôpital Bichat Paris France Not Yet Recruiting
Hôpital Cochin Paris France Not Yet Recruiting
Hôpital Pontchaillou, CHU de Rennes Rennes France Not Yet Recruiting
Hôpitaux universitaires de Strasbourg Strasbourg France Not Yet Recruiting
Hôpital Larrey, CHU de Toulouse Toulouse France Not Yet Recruiting
CHRU de Tours Tours France Not Yet Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04677205 on ClinicalTrials.gov ↗ ← All trials in France