AzTrials
AzTrials

Lung CancerN2-3SNCT04677205

Molecular Signature From Tumor to Lymph Nodes

An observational study of Lung Cancer and Stage IIIA-cN2, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
How many people
200 participants
Where
12 sitesFrance
Study dates
30 Mar 2021to Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 230 patients in 11 French centers in order to have 200 eligible patients. Objectives are 120 patients recruited retrospectively and 110 prospectively. Inclusion criteria are: all consecutive patients operated with a curative intent for an IIIA-cN2 NSCLC.

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Antoine LEGRAS, MD PhD contact

33 2 47474747

antlegras@gmail.com

Liliane HAMMANI-BERKANI, MSc contact

33 156093762

liliane.berkani@aphp.fr

12 sites in 1 country

France12 sites, 11 recruiting

  • Hôpital du Haut-Lévêque, CHU de Bordeaux

    Bordeaux

    Jacques JOUGON, Pr

    Not yet recruiting

  • Hôpital Militaire Percy

    Clamart

    Bertrand GRAND, Dr

    Not yet recruiting

  • Hôpital Nord

    Marseille

    Pascal THOMAS, Pr

    Not yet recruiting

  • Hôpital Pasteur, CHU de Nice

    Nice

    Jérome MOUROUX, Pr

    Not yet recruiting

  • Hegp-Aphp

    Paris, 75015

    Active, not recruiting

  • Hôpital Européen Georges-Pompidou

    Paris, 75015

    Françoise LE PIMPEC-BARTHES, Pr

    Recruiting

  • Hôpital Bichat

    Paris

    Pierre MORDANT, Dr

    Not yet recruiting

  • Hôpital Cochin

    Paris

    Marco ALIFANO, Pr

    Not yet recruiting

  • Hôpital Pontchaillou, CHU de Rennes

    Rennes

    Bertrand RICHARD DE LA TOUR, PR

    Not yet recruiting

  • Hôpitaux universitaires de Strasbourg

    Strasbourg

    MASSARD Gilbert, Pr

    Not yet recruiting

  • Hôpital Larrey, CHU de Toulouse

    Toulouse

    Laurent BROUCHET, Pr

    Not yet recruiting

  • CHRU de Tours

    Tours

    Antoine LEGRAS, Dr

    Not yet recruiting

Other trials in France

About this study

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

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.

Read the 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

Keywords
NSCLC, N2, molecular profile, prognosis
Medical subject headings
Lung Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year disease-free survival

    To identify a molecular signature based on a comprehensive molecular analysis at genomic and transcriptomic levels linked to 3-year disease-free survival in resected IIIA-N2 NSCLC.

    Measured: 3 years

Secondary outcomes (4)

  1. 5-year disease-free survival

    To identify a molecular signature based on a comprehensive molecular analysis at genomic and transcriptomic levels linked to 5-year disease-free survival in resected IIIA-N2 NSCLC.

    Measured: 5 years

  2. pathological architectural patterns WHO 2015 classification

    To evaluate the impact of the pathological architectural patterns WHO 2015 classification on the 5-year cancer-specific survival and the 5-year overall survival

    Measured: 5 years

  3. anatomical lymphatic spread

    To identify tumor molecular patterns associated with specific anatomical lymphatic spread subgroups.

    Measured: at the end of molecular analyses

  4. ctDNA

    To assess ctDNA prognostic impact, before and after surgery.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2020
  2. Study start30 Mar 2021
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04677205
Sponsor's protocol ID
D20180155
Other IDs
D20180155, 2019-A02635-52
Acronym
N2-3S
Status last verified
Jan 2023
First submitted
15 Dec 2020
Last updated
9 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

Publications

  • Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC Med. 2012 May 29;10:51. doi: 10.1186/1741-7015-10-51.

    PubMed 22642691

  • Legras A, Mordant P, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F, Riquet M. Long-term survival of patients with pN2 lung cancer according to the pattern of lymphatic spread. Ann Thorac Surg. 2014 Apr;97(4):1156-62. doi: 10.1016/j.athoracsur.2013.12.047. Epub 2014 Feb 26.

    PubMed 24582052

  • Lin IF, Chang WP, Liao YN. Shrinkage methods enhanced the accuracy of parameter estimation using Cox models with small number of events. J Clin Epidemiol. 2013 Jul;66(7):743-51. doi: 10.1016/j.jclinepi.2013.02.002. Epub 2013 Apr 6.

    PubMed 23566374

  • Pecuchet N, Rozenholc Y, Zonta E, Pietrasz D, Didelot A, Combe P, Gibault L, Bachet JB, Taly V, Fabre E, Blons H, Laurent-Puig P. Analysis of Base-Position Error Rate of Next-Generation Sequencing to Detect Tumor Mutations in Circulating DNA. Clin Chem. 2016 Nov;62(11):1492-1503. doi: 10.1373/clinchem.2016.258236. Epub 2016 Sep 13.

    PubMed 27624137

  • Peduzzi P, Concato J, Feinstein AR, Holford TR. Importance of events per independent variable in proportional hazards regression analysis. II. Accuracy and precision of regression estimates. J Clin Epidemiol. 1995 Dec;48(12):1503-10. doi: 10.1016/0895-4356(95)00048-8.

    PubMed 8543964

  • Tapak L, Saidijam M, Sadeghifar M, Poorolajal J, Mahjub H. Competing risks data analysis with high-dimensional covariates: an application in bladder cancer. Genomics Proteomics Bioinformatics. 2015 Jun;13(3):169-76. doi: 10.1016/j.gpb.2015.04.001. Epub 2015 Apr 20.

    PubMed 25907251

  • Um SW, Joung JG, Lee H, Kim H, Kim KT, Park J, Hayes DN, Park WY. Molecular Evolution Patterns in Metastatic Lymph Nodes Reflect the Differential Treatment Response of Advanced Primary Lung Cancer. Cancer Res. 2016 Nov 15;76(22):6568-6576. doi: 10.1158/0008-5472.CAN-16-0873. Epub 2016 Sep 13.

    PubMed 27634761

  • Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.

    PubMed 17182981

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer and Stage IIIA-cN2, run by Assistance Publique - Hôpitaux de Paris at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antoine LEGRAS, MD PhD (33 2 47474747, antlegras@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04677205, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in