Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Ongoing collection of blood and tumor samples from people with lung cancer

Official title: BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients

Run by Nantes University Hospital · NCT06481813 · Data updated 2026-11-12

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.

More Lung Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment730 (estimated)
SponsorNantes University Hospital
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations4 sites (Angers and 3 other locations)
StatusRecruiting
StartedDecember 10, 2024
Main results expectedDecember 1, 2029
Study endsDecember 1, 2034
Registry record updatedOctober 5, 2026
Trial IDNCT06481813 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous real-world biobanks and prospective oncology cohorts have contributed to biomarker discovery and understanding treatment response, although methods and populations have varied.

Who can join: the full rules

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 it's running

  • CHU Nantes
    Nantes, France
    Recruiting
  • CHU d'Angers
    Angers, France
    Not yet recruiting
  • CHU Rennes
    Rennes, France
    Not yet recruiting
  • CHU Tours
    Tours, France
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.