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

Официальное название

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

Обзор

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.

Вмешательства

• Другое Blood Sampling (2*8mL Tubes)
  Patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
• Другое PBMC Sampling (1*8mL Tubes)
  Patients will be sampled from 1 x 8 mL PBMC
• Другое Paxgene Sampling
  Patients will be sampled from 1 x 8 mL of blood with Paxgene Tube
• Процедура 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 s

Первичные конечные точки

• Overall survival [Срок оценки: up to 5 years]

Вторичные конечные точки (4)

• Describe the care pathway for patients with lung cancer. Assess the time intervals between different steps in the initial management of lung cancer. [Срок оценки: up to 5 years]
• Evaluate the return to work for patients of working age who have been treated for lung cancer. [Срок оценки: up to 5 years]
• Identify specific biomarkers of lung cancer cells (primary tumors or metastatic tissues) in comparison to healthy lung tissues. [Срок оценки: up to 5 years]
• Evaluate the prognostic and predictive value of circulating biomarkers at diagnosis and during systemic treatments. [Срок оценки: up to 5 years]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• CHU Nantes — Nantes

Идентификаторы

NCT: NCT06481813 · RC21_0541 · 2024-A00509-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗