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

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.

Conditions

• Cancer
• Malignancies Multiple
• Malignant Solid Tumor
• Cancer, Therapy-Related
• Molecular Sequence Variation
• Genetic Alteration
• Gene Fusion
• Receptor Tyrosine Kinase Gene Mutation
• RTK Family Gene Mutation
• Ras (Kras or Nras) Gene Mutation

Interventions

DRUG

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.

OTHER

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.

Sponsors & Collaborators

• Takeda Canada, Inc.

  collaborator INDUSTRY

• Applied Health Research Centre

  collaborator OTHER

• Programs for Assessment of Technology in Health Research Institute

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• Amgen

  collaborator INDUSTRY

• Bayer

  collaborator INDUSTRY

• Nuvation Bio Inc.

  collaborator INDUSTRY

• IQVIA Solutions Canada Inc.

  collaborator UNKNOWN

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Geoffrey Liu, MD, MSc · Princess Margaret Cancer Centre

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-17

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Canada

Study Locations