NCT06481813

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 730 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Small Cell Lung Carcinoma
• Metastatic Lung Cancer

Interventions

Type	Name	Description
OTHER	Blood Sampling (2*8mL Tubes)	Patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
OTHER	PBMC Sampling (1*8mL Tubes)	Patients will be sampled from 1 x 8 mL PBMC
OTHER	Paxgene Sampling	Patients will be sampled from 1 x 8 mL of blood with Paxgene Tube
PROCEDURE	Extended biopsies of tumor lesions	Regarding the ancillary study, as part of the care, patients are biopsied at diagnosis and during relapse(s). For metastatic patients with multiple sites, one site (the most accessible) is chosen and biopsied in interventional radiology or pulmonology. The material used is: 17-18G biopsy needle / Sampling chamber volume of 0.01 cm³ to 0.02 cm³. For a standard biopsy as part of the care, 3 samples are taken (total volume of 0.03 cm³ to 0.06 cm³). Inclusion in the ancillary study would add one sample using the same biopsy path, resulting in an additional volume of 0.01 cm³ to 0.02 cm³. In the case of a complex biopsy, no additional sampling related to the research will be performed.

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-12-01
• Completion: 2034-12-01
• First posted: 2024-07-01
• Last updated: 2026-01-21

Locations

1 site across 1 country: France