CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)
University Health Network, Toronto
5,500 participants
Jan 17, 2020
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria1
- 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
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Interventions
Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapies for their cancer treatment.
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.
Locations(27)
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NCT04151342