CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
  • Patient-reported outcomes (PROs)

Treatment groups

5,500 Participants
are divided into 3 treatment groups

Sponsors and collaborators

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