Molecular profiling of lung cancer and lymph nodes
Molecular Signature From Tumor to Lymph Nodes: How to Identify the Right Candidate for IIIA-N2 Lung Cancer Surgery?
This study is testing how the genetic makeup of lung tumors and lymph nodes in patients with early-stage lung cancer can help predict their recovery and guide better treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Bordeaux and 11 other locations) |
| Trial ID | NCT04677205 on ClinicalTrials.gov |
What this trial studies
This observational study aims to conduct a comprehensive molecular characterization of tumors and lymph nodes in patients with stage IIIA-cN2 non-small cell lung cancer (NSCLC) who have undergone surgery with curative intent. The study will analyze both primary tumor tissue and lymph node tissue to evaluate the impact of molecular signatures on disease-free survival. Additionally, circulating tumor DNA (ctDNA) will be assessed as a potential prognostic marker and surrogate for molecular heterogeneity, utilizing next-generation sequencing for accurate screening. The goal is to identify specific molecular profiles that may inform treatment strategies and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have undergone surgery for stage IIIA-cN2 NSCLC with curative intent.
Not a fit: Patients with advanced disease stages or those who have not undergone radical lymphadenectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for patients with stage IIIA-cN2 NSCLC, potentially improving their prognosis.
How similar studies have performed: Other studies have explored molecular profiling in lung cancer, but this specific approach focusing on N2 involvement and ctDNA analysis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 11 other locations
- Hôpital du Haut-Lévêque, CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- Hôpital Militaire Percy — Clamart, France (Not_yet_recruiting)
- Hôpital Nord — Marseille, France (Not_yet_recruiting)
- Hôpital Pasteur, CHU de Nice — Nice, France (Not_yet_recruiting)
- Hegp-Aphp — Paris, France (Active_not_recruiting)
- Hôpital Européen Georges-Pompidou — Paris, France (Recruiting)
- Hôpital Bichat — Paris, France (Not_yet_recruiting)
- Hôpital Cochin — Paris, France (Not_yet_recruiting)
- Hôpital Pontchaillou, CHU de Rennes — Rennes, France (Not_yet_recruiting)
- Hôpitaux universitaires de Strasbourg — Strasbourg, France (Not_yet_recruiting)
- Hôpital Larrey, CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
- CHRU de Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Helene BLONS, PharmD PhD — Hôpital Européen Georges-Pompidou
- Study coordinator: Antoine LEGRAS, MD PhD
- Email: antlegras@gmail.com
- Phone: 33 2 47474747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.