Actively Recruiting

Age: 18Years +
All Genders
NCT04677205

Molecular Signature From Tumor to Lymph Nodes

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-01-09

200

Participants Needed

12

Research Sites

343 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

N

National Cancer Institute, France

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Molecular Signature From Tumor to Lymph Nodes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • Patient with T4, R1 or R2 surgical resection, sublobar resection, no radical lymphadenectomy
  • Patient under protectives measures
  • Pregnancy or breast-feeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 12 locations

1

Hôpital du Haut-Lévêque, CHU de Bordeaux

Bordeaux, France

Not Yet Recruiting

2

Hôpital Militaire Percy

Clamart, France

Not Yet Recruiting

3

Hôpital Nord

Marseille, France

Not Yet Recruiting

4

Hôpital Pasteur, CHU de Nice

Nice, France

Not Yet Recruiting

5

Hegp-Aphp

Paris, France, 75015

Active, Not Recruiting

6

Hôpital Européen Georges-Pompidou

Paris, France, 75015

Actively Recruiting

7

Hôpital Bichat

Paris, France

Not Yet Recruiting

8

Hôpital Cochin

Paris, France

Not Yet Recruiting

9

Hôpital Pontchaillou, CHU de Rennes

Rennes, France

Not Yet Recruiting

10

Hôpitaux universitaires de Strasbourg

Strasbourg, France

Not Yet Recruiting

11

Hôpital Larrey, CHU de Toulouse

Toulouse, France

Not Yet Recruiting

12

CHRU de Tours

Tours, France

Not Yet Recruiting

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Research Team

A

Antoine LEGRAS, MD PhD

CONTACT

L

Liliane HAMMANI-BERKANI, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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