Pan-Canadian Lung Cancer Observational Study (PALEOS)

Titre officiel

Pan-Canadian Lung Cancer Observational Study (PALEOS)

Sommaire:

Cette étude est une étude d’observation multicentrique et ambispective qui recueillera des données sur les patients atteints de cancers du poumon au Canada. L’étude commencera avec des patients qui présentent une mutation des gènes ALK, EGFR, ROS1 et ERBB2 (HER2), une mutation de l’exon 20 de l’EGFR et une mutation des gènes MET et BRAF, et aura pour but de s’étendre à d’autres altérations moléculaires rares la deuxième année.

Description de l'essai

Primary Outcome:

  • Treatment effectiveness
  • Outcome of Patients
Lung cancer is no longer considered a single entity. In the new world of lung cancer, it consists of many subgroups that are defined in different ways by different clinicians and researchers. In broad categories, these include sociodemographic, molecular, treatment, or biomarker-driven subgroups, to name a few. As a result, the single-centre study of lung cancer is not viable, as no single centre has adequate numbers of each subgroup to study by themselves. PALEOS is designed to use the power of a multi-institutional study to evaluate these important questions of natural history, treatment patterns, outcomes as they relate to new diagnostic, new biomarkers, and new treatments. Real-world data will be generated by PALEOS. Thus, there will be a broader understanding of how treatments and outcomes that were originally studied in the clinical trial setting would now be translated into the real-world setting.

Primary Study Objectives:
  • To report on the natural history of multiple subgroups of lung cancer patients (regardless of stage) in Canada, from 2006 onwards, using a combination of retrospective and prospective methods that includes diagnostic, molecular alterations, treatment, and outcomes.
  • To report the real-world treatment patterns of all and specific subgroups of lung cancer patients in Canada, across time (from 2006 onwards), geography.
  • To recruit from centres that are representative of Canadian patients seen in both academic and community cancer settings.

Secondary Study Objectives:
  • To evaluate patient-reported outcomes of different subgroups of lung cancer, through all phases of the disease, from diagnosis through to end-of-life.
  • To understand the incidence, prevalence, and outcomes (efficacy and toxicity), and patterns of locoregional and metastatic spread of different subgroups of lung cancer.
  • To understand the evolution of clinical implementation of new diagnostic tests, new biomarker tests, new treatments (whether it be surgical, medical, radiation, or other), including access by healthcare teams and patients, their rates of adoption into clinical practice, and retention of overtime.
  • To develop economic models for various subgroups of lung cancer patients based on the accumulated data within the PALEOS study.
  • To compare the natural history, stage distribution, treatment outcomes such as treatment effectiveness (composite of disease progression or death), and treatment toxicities (where available) across sub-group of patients with tumours that have been molecularly subtyped and identified to have rare molecular alterations.

Voir cet essai sur ClinicalTrials.gov

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Ressources

Société canadienne du cancer

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