Canadian Rare Molecular Alteration Basket Real-world Observational Study is the first basket observational cancer study in Canada. Subsets of patients in this first round of study include ALK, ROS1, BRAF, and EGFR exon 20. Additional molecular baskets may be added over time, depending on funding.
To study rare subsets of molecularly targetable lung cancer, such as ALK, ROS1, NTRK fusions or EGFR mutations, a novel infrastructure adapted from the clinical trial world is needed. This infrastructure must allow rapid identification of these patients, connects them with appropriate treatment options, and allows us to observe the outcomes. These data are needed for scientific discovery by linking their clinicodemographic, treatment, and outcomes data (and potentially biospecimens) across Canada.
What are the unique cancer features of different rare molecular alterations in Canada?
This investigator-initiated study from the laboratory is a national trial to study the impact of being diagnosed with a rare molecular alteration in cancer across Canada. This real world observational study will collect clinico-demographic and patient reported data (see CHUQoLS for more detail about the experience with patient reported tools). The study is flexible, allowing new biomarkers to be studied easily across Canada. This study will capture data both retrospectively and prospectively, so that we can understand the course of a patient’s disease from diagnosis.
During and at the end of this multi-year study, we will have a robust database from which to better understand how these patients are managed in the real world in Canada, and their outcomes. We will be able to use their collected data to analyze trends in adoption of new biomarkers and treatments. We can also use this study to springboard specialized molecular-based research, as there will be a mechanism to identify and re-contact these patients for additional studies (including those that may involve their tissue).
(1) To understand the natural history of patients with rare molecular alterations on current treatments, including outcomes and patient-reported outcomes;
(2) To evaluate the impact of new treatments on outcomes outside of the clinical trials realm;
(3) To utilize these data for health economic and outcomes research (HEOR) analyses.
Funding Sources: Multiple Pharmaceutical companies