Molecular Signature From Tumor to Lymph Nodes
Recruiting · NCT04677205 · Observational (researchers observe without assigning treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
12 locations listed.
- 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