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

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ClinicalTrials.gov Identifier: NCT04677205
Recruitment Status : Not yet recruiting
First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborators:
National Cancer Institute, France
Ministry of Health, France
Université de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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%. 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.


Condition or disease
Lung Cancer Stage IIIA-cN2 Operated With Curative Intent Primary Tumor Tissue Available Node Tumor Tissue Available

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Tumor DNA, Tumor RNA, cell free DNA from blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677205


Contacts
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Contact: Antoine LEGRAS, MD PhD 33 2 47474747 antlegras@gmail.com
Contact: Liliane HAMMANI-BERKANI, MSc 33 156093762 liliane.berkani@aphp.fr

Locations
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France
Hôpital du Haut-Lévêque, CHU de Bordeaux
Bordeaux, France
Contact: Jacques JOUGON, Pr         
Hôpital Militaire Percy
Clamart, France
Hôpital Nord
Marseille, France
Contact: Pascal THOMAS, Pr         
Hôpital Pasteur, CHU de Nice
Nice, France
Hegp-Aphp
Paris, France, 75015
Hôpital Européen Georges-Pompidou
Paris, France, 75015
Contact: Françoise LE PIMPEC-BARTHES, Pr         
Hôpital Bichat
Paris, France
Hôpital Cochin
Paris, France
Contact: Marco ALIFANO, Pr         
Hôpital Pontchaillou, CHU de Rennes
Rennes, France
Hôpitaux universitaires de Strasbourg
Strasbourg, France
Contact: MASSARD Gilbert, Pr         
Hôpital Larrey, CHU de Toulouse
Toulouse, France
Contact: Laurent BROUCHET, Pr         
CHRU de Tours
Tours, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Cancer Institute, France
Ministry of Health, France
Université de Paris
Investigators
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Principal Investigator: Helene BLONS, PharmD PhD Hôpital Européen Georges-Pompidou
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04677205    
Other Study ID Numbers: D20180155
D20180155 ( Other Identifier: Assistance Publique - Hôpitaux de Paris )
2019-A02635-52 ( Other Identifier: N° IDRCB )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Two years after the last publication
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).


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
NSCLC
N2
molecular profile
prognosis
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases