Molecular Signature From Tumor to Lymph Nodes (N2-3S)

January 6, 2023 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Not yet recruiting
        • Hôpital du Haut-Lévêque, CHU de Bordeaux
        • Contact:
          • Jacques JOUGON, Pr
      • Clamart, France
        • Not yet recruiting
        • Hôpital MILITAIRE PERCY
        • Contact:
          • Bertrand GRAND, Dr
      • Marseille, France
        • Not yet recruiting
        • Hôpital Nord
        • Contact:
          • Pascal THOMAS, Pr
      • Nice, France
        • Not yet recruiting
        • Hôpital Pasteur, CHU de Nice
        • Contact:
          • Jérome MOUROUX, Pr
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges-Pompidou
        • Contact:
          • Françoise LE PIMPEC-BARTHES, Pr
      • Paris, France
        • Not yet recruiting
        • Hopital Cochin
        • Contact:
          • Marco ALIFANO, Pr
      • Paris, France
        • Not yet recruiting
        • Hopital Bichat
        • Contact:
          • Pierre MORDANT, Dr
      • Paris, France, 75015
        • Active, not recruiting
        • Hegp-Aphp
      • Rennes, France
        • Not yet recruiting
        • Hôpital Pontchaillou, CHU de Rennes
        • Contact:
          • Bertrand RICHARD DE LA TOUR, PR
      • Strasbourg, France
        • Not yet recruiting
        • Hopitaux Universitaires de Strasbourg
        • Contact:
          • MASSARD Gilbert, Pr
      • Toulouse, France
        • Not yet recruiting
        • Hôpital Larrey, CHU de Toulouse
        • Contact:
          • Laurent BROUCHET, Pr
      • Tours, France
        • Not yet recruiting
        • CHRU de Tours
        • Contact:
          • Antoine LEGRAS, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease-free survival
Time Frame: 3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year disease-free survival
Time Frame: 5 years
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.
5 years
pathological architectural patterns WHO 2015 classification
Time Frame: 5 years
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
5 years
anatomical lymphatic spread
Time Frame: at the end of molecular analyses
To identify tumor molecular patterns associated with specific anatomical lymphatic spread subgroups.
at the end of molecular analyses
ctDNA
Time Frame: 3 years
To assess ctDNA prognostic impact, before and after surgery.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ministry of Health, France
National Cancer Institute, France
Université de Paris

Investigators

  • Principal Investigator: Helene BLONS, PharmD PhD, Hôpital Européen Georges-Pompidou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2027

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D20180155 (Other Identifier: Assistance Publique - Hôpitaux de Paris)
  • 2019-A02635-52 (Other Identifier: N° IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

IPD Sharing Time Frame

Two years after the last publication

IPD Sharing Access Criteria

Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.

Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe