NCT06481813 Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
| NCT ID | NCT06481813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 730 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 730 participants in total. It began in 2024-12-10 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06481813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06481813 currently recruiting?
Yes, NCT06481813 is actively recruiting participants. Contact the research team at elvire.pons@chu-nantes.fr for enrollment information.
Where is the NCT06481813 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT06481813 clinical trial?
NCT06481813 is sponsored by Nantes University Hospital. The trial plans to enroll 730 participants.
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