CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
This study will collect data on Canadian cancer patients that have uncommon/rare changes in
 their tumours, such as alterations/rearrangements in the genetic material inside cells -
 known as deoxyribonucleic acid, or DNA, which acts as a map and gives directions to the cells
 on how to make other substances the body needs - because some of these changes have been
 found to respond to different drugs that help to stop the cancer. These rare changes occur in
 genes such as but not limited to ALK, EGFR exon 20, ROS1, and BRAF, which have targeted drugs
 in a family known as tyrosine kinase inhibitors (TKIs). The goals for the study are to
 compare the natural history of such cancers and the treatment outcomes, including toxicities
 and patient-reported outcomes, for the different therapies.
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:

 1. 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.

 2. 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:

 3. 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.

 4. 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.

 5. To assess quality of life in patients with rare molecular alterations across different
 stages, lines and types of therapy.

 6. To perform exploratory health economic evaluations focused on the costs and benefits of
 managing patients with rare molecular alterations.

 7. To perform biomarker analyses, where appropriate, to improve our understanding of these
 rare molecular alterations.
Inclusion Criteria:

 -  Patients ≥ 18 years at cancer diagnosis

 -  Diagnosed with malignant tumour(s) with molecular testing completed that identified
 rare molecular alterations

 -  Accessible/available molecular testing reports/documentation to confirm type(s) of
 molecular alteration(s) (resulting from the conduct of polymerase chain reaction [PCR]
 based next generation sequencing [NGS], immunohistochemistry [IHC], fluorescence in
 situ hybridization [FISH])

 -  Canadian resident received follow-up for cancer care in Canada or is currently
 receiving/planning follow-up for cancer care to occur in Canada at time of enrollment

 Exclusion Criteria:

 -  Previous refusal of the deceased patient, when living, to enroll in this study or
 patient approached for this study is unable to provide informed consent