CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
NCT ID: NCT04151342
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5500 participants
OBSERVATIONAL
2020-01-17
2029-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Prospective
Living cancer patients with histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.
Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapies for their cancer treatment.
Patient-reported outcomes (PROs)
Prospectively enrolled participants will be provided with survey packets comprised of different PRO instruments at the initial/baseline visit, at 3 month follow up intervals and at the time when treatment/therapy is changed.
Retrospective
Deceased cancer patients who had histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.
Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapies for their cancer treatment.
Comparator group
All cancer patients without rare molecular alterations in their solid tumours. This group will be established in order to determine baseline characteristics and outcomes, including treatment outcomes, of more standard treatments such as systemic chemotherapy or immunotherapy.
No interventions assigned to this group
Interventions
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Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapies for their cancer treatment.
Patient-reported outcomes (PROs)
Prospectively enrolled participants will be provided with survey packets comprised of different PRO instruments at the initial/baseline visit, at 3 month follow up intervals and at the time when treatment/therapy is changed.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Takeda Canada, Inc.
INDUSTRY
Applied Health Research Centre
OTHER
Programs for Assessment of Technology in Health Research Institute
OTHER
AstraZeneca
INDUSTRY
Amgen
INDUSTRY
Bayer
INDUSTRY
Nuvation Bio Inc.
INDUSTRY
IQVIA Solutions Canada Inc.
UNKNOWN
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Geoffrey Liu, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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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
St. 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
Health Sciences North
Greater Sudbury, 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
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)
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur-de-Montréal (HSCM)
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
St. Mary's Hospital Center
Montreal, Quebec, Canada
Centre hospitalier de l'université de Québec - Université Laval
Québec, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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18-5902
Identifier Type: OTHER
Identifier Source: secondary_id
1632
Identifier Type: OTHER
Identifier Source: secondary_id
CARMA-BROS
Identifier Type: -
Identifier Source: org_study_id
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