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

Study acronym: BREATHE
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 23 words
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2024 to Dec 10, 2024
    v3
  3. Notable Start date: Sep 1, 2024 to Dec 1, 2024v2 Show 7 more changesShow less
    • Enrollment target: 700 to 730
    • Primary completion date: Sep 1, 2029 to Dec 1, 2029
    • Study completion date: Sep 1, 2034 to Dec 1, 2034
    • Interventions: Blood Sampling (2*8mL Tubes) (Other), PBMC Sampling (1*8mL Tubes) (Other), Paxgene Sampling (Other) to Blood Sampling (2*8mL Tubes) (Other), Extended biopsies of tumor lesions (Procedure), PBMC Sampling (1*8mL Tubes) (Other), Paxgene Sampling…
    • Secondary endpoints expanded, about 73 words
    • Study arms: 5 to 6
    • Eligibility criteria expanded, about 3 words
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06481813
Lead Sponsor Nantes University Hospital
Conditions
(from sponsor)
Lung Cancer, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Metastatic Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Small Cell Lung Carcinoma
Enrollment 730 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov