Clinical trial NCT06481813: Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
Official title: BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Cancer
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Metastatic Lung Cancer
Keywords: Real-world cohort
Lung Cancer
Biobank
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This cohort will include 5 distinct patient populations.
Primary purpose: BASIC_SCIENCE

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

Primary outcomes:
measure: Overall survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Describe the care pathway for patients with lung cancer. Assess the time intervals between different steps in the initial management of lung cancer.
timeFrame: up to 5 years
measure: Evaluate the return to work for patients of working age who have been treated for lung cancer.
timeFrame: up to 5 years
measure: Identify specific biomarkers of lung cancer cells (primary tumors or metastatic tissues) in comparison to healthy lung tissues.
timeFrame: up to 5 years
measure: Evaluate the prognostic and predictive value of circulating biomarkers at diagnosis and during systemic treatments.
timeFrame: up to 5 years
Other outcomes:
measure: Predicting the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.
timeFrame: up to 5 years
measure: Determining the mechanisms of resistance development to KRAS G12C inhibitors through longitudinal analysis of tumor and plasma samples.
timeFrame: up to 5 years
measure: Determining whether transcriptional changes under sotorasib or adagrasib can predict progression-free survival in patients with metastatic KRAS G12C-mutated NSCLC.
timeFrame: up to 5 years
measure: Assessing the prognostic value of detecting specific molecular alterations occurring under treatment.
timeFrame: up to 5 years
measure: Identifying whether new molecular alterations can be detected in tumor and plasma samples from patients at progression.
timeFrame: up to 5 years
Locations:
Study officials:
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