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.
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
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
Cancer patients living and deceased who have/had a histologically confirmed rare molecular alteration in their tumours, such as but not limited to ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.
Cohort
Other
Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
DrugObserving 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)
Other interventionProspectively 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.
Composite of Progression Free Survival [PFS] or Overall Survival [OS]
Composite of disease progression or death
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)
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)
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.
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.
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Takeda Canada, Inc.
Collaborator
Applied Health Research Centre
Collaborator
Programs for Assessment of Technology in Health Research Institute
Collaborator
AstraZeneca
Collaborator
Amgen
Collaborator
Bayer
Collaborator
Nuvation Bio Inc.
Collaborator
IQVIA Solutions Canada Inc.
Collaborator
