CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)

Titre officiel

CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)

Sommaire:

Cette étude permettra de recueillir des données sur les patients canadiens atteints de cancer qui présentent des changements rares/peu fréquents dans leurs tumeurs, comme des altérations/réarrangements du matériel génétique à l’intérieur des cellules – connu sous le nom d’acide désoxyribonucléique, ou ADN, qui agit comme une carte et indique aux cellules comment fabriquer d’autres substances dont le corps a besoin. En effet, il a été constaté que les tumeurs qui présentent certains de ces changements répondent à différents médicaments qui aident à arrêter le cancer. Ces changements rares se produisent dans des gènes tels que ALK, EGFR (exon 20), ROS1 et BRAF, qui sont des cibles d’une famille de médicaments connus sous le nom d’inhibiteurs de la tyrosine kinase (ITK). Les objectifs de l’étude sont de comparer l’histoire naturelle de ces cancers et les résultats des divers traitements, y compris la toxicité et les résultats signalés par les patients.

Description de l'essai

Primary Outcome:

• Composite of Progression Free Survival [PFS] or Overall Survival [OS]

Secondary Outcome:

• Brain metastasis/other metastatic tumours
• EORTC quality of life questionnaires (QLQ) - cancer patient-reported health related quality of life
• EQ-5D-5L - patient-reported health related quality of life measure
• Patient-reported economic impact

Molecular heterogeneity in cancer tumours make it a complex disease to manage and treat. However, there have been significant advancements made in the detection of molecular alterations and we are able to now define distinct disease subtypes which permit targeted selection of therapies, thus optimizing treatment responses for patients and improving their survival.

With CARMA-BROS we will address the objectives that follow.

Primary Objectives:

• To create a cohort of patients through which to better understand the natural history of disease in Canadian cancer patients with tumours that have been molecularly subtyped and identified to have rare molecular alterations.
• To compare the natural history, stage distribution, treatment outcomes such as treatment effectiveness (composite of disease progression or death) and treatment toxicities across different patients with different molecular alterations, receiving different lines and types of therapy. Secondary Objectives:
• To determine the incidence, time to development, prevalence, and outcomes of patients with specific patterns of spread, such as brain metastases compared to those without, by different therapies and by molecular alterations.
• To better understand real-world treatment patterns of rare molecular alterations in the Canadian context, across geographic or other factors, and how treatment patterns evolve over time and as new therapies become available, how patients are investigated and how targeted and other biomarkers are used as part of clinical practice in these patients.
• To assess quality of life in patients with rare molecular alterations across different stages, lines and types of therapy.
• To perform exploratory health economic evaluations focused on the costs and benefits of managing patients with rare molecular alterations.
• To perform biomarker analyses, where appropriate, to improve our understanding of these rare molecular alterations.

Voir cet essai sur ClinicalTrials.gov