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NCT Number: NCT04677205

Molecular Signature From Tumor to Lymph Nodes

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Node Tumor Tissue Available Operated With Curative Intent Primary Tumor Tissue Available Respiratory Tract Diseases Respiratory Tract Neoplasms Stage IIIA-cN2 Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital du Haut-Lévêque, CHU de Bordeaux, Bordeaux, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. anatomical lymphatic spread

    Time frame: at the end of molecular analyses

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

  4. ctDNA

    Time frame: 3 years

    To assess ctDNA prognostic impact, before and after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine LEGRAS, MD PhD

CONTACT

[email protected]

33 2 47474747

Liliane HAMMANI-BERKANI, MSc

CONTACT

[email protected]

33 156093762

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

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

Registry information

Official study title

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

Acronym: N2-3S

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Dec 21, 2020
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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