Cancer Clinical Trial
— CARMA-BROSOfficial title:
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, 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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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], liquid biopsy) - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | William Osler Health System - Brampton Civic Hospital | Brampton | Ontario |
Canada | 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 | Dr. Everett Chalmers Regional Hospital | Fredericton | New Brunswick |
Canada | Queen Elizabeth II (QEII) Health Sciences Centre | Halifax | Nova Scotia |
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 | 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 | Ottawa Hospital Cancer Centre | Ottawa | Ontario |
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 | Allan Blair Cancer Centre | Regina | Saskatchewan |
Canada | Dr. H. Bliss Murphy Cancer Centre | Saint John's | Newfoundland and Labrador |
Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
Canada | Centre hospitalier universitaire de Sherbrooke (CHUS) | Sherbrooke | Quebec |
Canada | Health Sciences North | Sudbury | Ontario |
Canada | Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN) | Toronto | Ontario |
Canada | Sunnybrook Research Institute - Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | BC Cancer | Vancouver | British Columbia |
Canada | CancerCare Manitoba/University of Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Amgen, AnHeart Therapeutics Inc., Applied Health Research Centre, AstraZeneca, Bayer, Programs for Assessment of Technology in Health Research Institute, Takeda Canada, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of Progression Free Survival [PFS] or Overall Survival [OS] | Composite of disease progression or death | From the start date of cancer therapy until the date of first documented progression or date of death (any cause), assessed up to 120 months | |
Secondary | Brain metastasis/other metastatic tumours | Confirmed through imaging (MRI, CT) or determined through treatment indication(s), for example, brain radiation therapy (surrogate for presence of brain metastasis) | From the start date of cancer therapy until the date of first documented brain/other metastasis, assessed up to 120 months | |
Secondary | EORTC quality of life questionnaires (QLQ) - cancer patient-reported health related quality of life | Prospectively enrolled participants will complete the following health related quality of life surveys: EORTC QLQ-C30 (core) and EORTC QLQ-LC13 (disease specific module) | Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study) | |
Secondary | EQ-5D-5L - patient-reported health related quality of life measure | Prospectively enrolled participants will complete the health related quality of life survey: EQ-5D-5L. | Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study) | |
Secondary | Patient-reported economic impact | Prospectively enrolled participants will complete the "Work Productivity and Activity Impairment Questionnaire: General Health" (WPAI:GH) and other economic impact questions that capture indirect costs incurred as a result of their disease. | Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study) |
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