Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06481813

Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients

Led by Nantes University Hospital · Updated on 2026-01-21

730

Participants Needed

1

Research Sites

520 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study). In parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.

CONDITIONS

Official Title

Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients
  • Newly diagnosed with non-small-cell lung cancer (NSCLC) or small cell lung carcinoma (CPC)
  • Receiving care at Nantes University Hospital
  • Affiliated with or beneficiary of a social security scheme or similar
  • Treated with systemic therapy including chemotherapy, immunotherapy, targeted therapy, or therapy as part of a clinical trial without blinding
  • Provided signed consent to participate in the biocollection
  • Healthy subjects must be adults
  • Healthy subjects must have no known infectious disease, cancer history, chronic autoimmune disease, or immunosuppressive treatment
  • Healthy subjects must provide signed consent
  • For ancillary study: metastatic NSCLC with KRAS G12C mutation receiving treatment with Sotorasib, Adagrasib, or other KRAS G12C inhibitor, alone or in combination
Not Eligible

You will not qualify if you...

  • Previous anticancer treatment for lung cancer
  • Not consenting to participate in the BREATHE collection
  • History of cancer (excluding thoracic cancer) with disease evidence within last 2 years
  • Participation in a therapeutic trial with blinded treatment
  • Under legal guardianship
  • Receiving State medical aid (AME)
  • Pregnant or breastfeeding women
  • For healthy subjects: under legal guardianship, receiving AME, pregnant or breastfeeding
  • For ancillary study: pregnant or breastfeeding women

AI-Screening

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Trial Site Locations

Total: 1 location

1

CHU Nantes

Nantes, France

Actively Recruiting

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Research Team

E

Elvire PONS-TOSTIVINT, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

6

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