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NCT04677205Recruiting

Molecular Signature From Tumor to Lymph Nodes

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

Source: ClinicalTrials.gov · Last updated 9 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
15 Dec 2020
Start date
30 Mar 2021
Primary completion date
Nov 2023
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Lung cancer
NCT number
NCT04677205

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 30 Mar 2021 to the primary completion date, Nov 2023
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient with T4, R1 or R2 surgical resection, sublobar resection, no radical lymphadenectomy

Other

  • Patient under protectives measures
  • Pregnancy or breast-feeding

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital du Haut-Lévêque, CHU de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
Hôpital Militaire Percy
Coordinator of this site? Confirm its status
ClamartFranceNot yet recruiting
Hôpital Nord
Coordinator of this site? Confirm its status
MarseilleFranceNot yet recruiting
Hôpital Pasteur, CHU de Nice
Coordinator of this site? Confirm its status
NiceFranceNot yet recruiting
Hôpital Cochin
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
Hôpital Bichat
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
Hôpital Européen Georges Pompidou
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hegp-Aphp
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Hôpital Pontchaillou, CHU de Rennes
Coordinator of this site? Confirm its status
RennesFranceNot yet recruiting
Hopitaux Universitaires de Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceNot yet recruiting
Hôpital Larrey - CHU de Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceNot yet recruiting
CHRU de Tours
Coordinator of this site? Confirm its status
ToursFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.