Ongoing collection of blood and tumor samples from people with lung cancer
BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
NA · Nantes University Hospital · NCT06481813
Collect and store blood and tumor samples over time from adults with newly diagnosed or metastatic lung cancer to build a real-world biobank for research.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 730 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Nantes) |
| Trial ID | NCT06481813 on ClinicalTrials.gov |
What this trial studies
This prospective, longitudinal cohort at Nantes University Hospital collects serial blood, PBMC, Paxgene, and tumor biopsy samples from adults with various lung cancer types and stages, along with healthy volunteer controls. Participants who are newly diagnosed or have metastatic disease and who receive systemic therapy (chemotherapy, targeted therapy, immunotherapy, or unblinded trial drugs) provide samples at scheduled visits to link molecular data with treatments and outcomes. All participants sign informed consent for biobanking and long-term storage for molecular and translational research, including an ancillary arm for KRAS G12C–mutant metastatic NSCLC treated with KRAS inhibitors. The design captures real-world diversity in age, comorbidities, and co-medications that are often underrepresented in controlled trials.
Who should consider this trial
Good fit: Adults receiving care at Nantes University Hospital who are newly diagnosed with or have metastatic lung cancer and can provide informed consent, plus healthy adult volunteers for control samples.
Not a fit: People seeking direct therapeutic benefit from participation—or patients unable or unwilling to provide serial blood or tissue samples or to attend visits at Nantes—are unlikely to gain direct clinical benefit from enrollment.
Why it matters
Potential benefit: If successful, the biobank could help researchers discover biomarkers and better understand how lung cancer treatments work in real-world patients, including groups often excluded from clinical trials.
How similar studies have performed: Previous real-world biobanks and prospective oncology cohorts have contributed to biomarker discovery and understanding treatment response, although methods and populations have varied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients : * Adult * Patient newly diagnosed with NSCLC or CPC * Cared for at Nantes University Hospital * Affiliated or beneficiaries of a social security scheme or similar * Treated with a systemic therapy including chemotherapy and/or immunotherapy and/or targeted therapy and/or therapy as part of a clinical trial after agreement from the sponsors of the studies concerned (only in the absence of blinding). * Having agreed to participate in this study by signing the biocollection consent. Healthy subjects : * Adult * Affiliated or beneficiaries of a social security or similar scheme * Who have agreed to participate in this study by signing the Biocollection consent form. * No known infectious pathology * No known history of cancer * No known history of chronic autoimmune disease * No background immuno-suppressive treatment Ancillary Study : -Metastatic NSCLC with a KRAS G12C mutation, receiving treatment with Sotorasib, Adagrasib, or another KRAS G12C inhibitor, either as monotherapy or in combination. Exclusion Criteria: Patients : * Previous anticancer treatment for Lung cancer * Patients who have not consented to participate in the BREATHE collection * History of cancer (excluding thoracic cancer) with evidence of disease for less than 2 years * Inclusion in a therapeutic trial with blinded treatment * Patients under guardianship * Patients with AME. * Pregnant or breast-feeding women Healthy subjects : * Person under guardianship * Person benefiting from AME (State medical aid) * Pregnant or breast-feeding women Ancillary Study : \- Pregnant or breast-feeding women
Where this trial is running
Nantes
- CHU Nantes — Nantes, France (RECRUITING)
Study contacts
- Study coordinator: Elvire PONS-TOSTIVINT, MD PhD
- Email: elvire.pons@chu-nantes.fr
- Phone: 02.40.16.59.30
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.
Conditions: Lung Cancer, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Metastatic Lung Cancer, Real-world cohort, Biobank