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Brief Title: CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
Official Title: CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
Study ID: NCT04151342
Brief Summary: 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, ROS1, BRAF, and NTRK which have targeted drugs in a family known as tyrosine kinase inhibitors (TKIs), and KRAS G12C mutation, which now has a targeted inhibitor drug therapy for patients with non small cell lung cancer (NSCLC). 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tom Baker Cancer Centre - University of Calgary - Alberta Health Services, Calgary, Alberta, Canada
Cross Cancer Institute, University of Alberta - Alberta Health Services, Edmonton, Alberta, Canada
BC Cancer, Vancouver, British Columbia, Canada
CancerCare Manitoba/University of Manitoba, Winnipeg, Manitoba, Canada
Dr. Everett Chalmers Regional Hospital, Fredericton, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, Saint John's, Newfoundland and Labrador, Canada
Queen Elizabeth II (QEII) Health Sciences Centre, Halifax, Nova Scotia, Canada
William Osler Health System - Brampton Civic Hospital, Brampton, Ontario, Canada
Hamilton Health Sciences - Juravinski Cancer Centre, Hamilton, Ontario, Canada
Kingston Health Sciences Centre (KHSC), Kingston, Ontario, Canada
Lawson Health Research Institute - London Health Sciences Centre, London, Ontario, Canada
Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Health Sciences North, Sudbury, Ontario, Canada
Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN), Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Sunnybrook Research Institute - Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM), Montréal, Quebec, Canada
Hôpital du Sacré-Coeur-de-Montréal (HSCM), Montréal, Quebec, Canada
Jewish General Hospital, Montréal, Quebec, Canada
McGill University Health Centre, Montréal, Quebec, Canada
St. Mary's Hospital Center, Montréal, Quebec, Canada
Centre hospitalier de l'université de Québec - Université Laval, Québec City, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec, Québec City, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Name: Geoffrey Liu, MD, MSc
Affiliation: Princess Margaret Cancer Centre
Role: PRINCIPAL_INVESTIGATOR