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

November 25, 2025 updated by: University Health Network, Toronto
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Molecular heterogeneity in cancer tumours make it a complex disease to manage and treat. However, there have been significant advancements made in the detection of molecular alterations and we are able to now define distinct disease subtypes which permit targeted selection of therapies, thus optimizing treatment responses for patients and improving their survival.

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.

Study Type

Observational

Enrollment (Estimated)

5500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Recruiting
        • Tom Baker Cancer Centre - University of Calgary - Alberta Health Services
        • Contact:
        • Principal Investigator:
          • Vishal Navani, MA (Oxon), MBBS, MRCP, FRACP
      • Edmonton, Alberta, Canada
        • Not yet recruiting
        • Cross Cancer Institute, University of Alberta - Alberta Health Services
        • Contact:
        • Principal Investigator:
          • Quincy Siu-Chung Chu, MD, FRCPC
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Recruiting
        • CancerCare Manitoba/University of Manitoba
        • Contact:
        • Principal Investigator:
          • Shantanu Banerji, MD, FRCPC
    • New Brunswick
      • Fredericton, New Brunswick, Canada
        • Recruiting
        • Dr. Everett Chalmers Regional Hospital
        • Contact:
        • Principal Investigator:
          • Luisa Galvis-Gomez, MD
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Not yet recruiting
        • Dr. H. Bliss Murphy Cancer Centre
        • Contact:
        • Principal Investigator:
          • Elizabeth Faour, MD
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • Queen Elizabeth II (QEII) Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Stephanie Snow, MD, FRCPC
    • Ontario
      • Brampton, Ontario, Canada
        • Recruiting
        • William Osler Health System - Brampton Civic Hospital
        • Contact:
        • Principal Investigator:
          • Parneet Cheema, MD, FRCPC
      • Greater Sudbury, Ontario, Canada
        • Recruiting
        • Health Sciences North
        • Contact:
        • Principal Investigator:
          • Abhenil Mittal, MD
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton Health Sciences - Juravinski Cancer Centre
        • Contact:
        • Principal Investigator:
          • Rosalyn Juergens, MD, PhD
      • Kingston, Ontario, Canada
        • Recruiting
        • Kingston Health Sciences Centre (KHSC)
        • Contact:
        • Principal Investigator:
          • Sofia Genta, MD
      • London, Ontario, Canada
        • Recruiting
        • Lawson Health Research Institute - London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Sara Kuruvilla, MD, FRCPC
      • Ottawa, Ontario, Canada
        • Recruiting
        • Ottawa Hospital Cancer Centre
        • Contact:
        • Principal Investigator:
          • Paul Wheatley-Price, MBChB, FRCP(UK), MD
      • Thunder Bay, Ontario, Canada
        • Not yet recruiting
        • Thunder Bay Regional Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Olexiy Aseyev, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Ronald Burkes, MD, FRCPC
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN)
        • Principal Investigator:
          • Geoffrey Liu, MD, MSc
        • Contact:
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Research Institute - Sunnybrook Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Ines Menjak, MD, FRCPC
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Jewish General Hospital
        • Principal Investigator:
          • Jason Agulnik, MD
        • Contact:
      • Montreal, Quebec, Canada
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
        • Principal Investigator:
          • Normand Blais, MD, MSc
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Jonathan Spicer, MD, PhD
      • Montreal, Quebec, Canada
        • Recruiting
        • Hôpital du Sacré-Coeur-de-Montréal (HSCM)
        • Contact:
        • Principal Investigator:
          • Kevin Jao, MD, PhD
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • St. Mary's Hospital Center
        • Principal Investigator:
          • Nicholas Meti, MD
        • Contact:
      • Québec, Quebec, Canada
        • Not yet recruiting
        • Centre hospitalier de l'université de Québec - Université Laval
        • Contact:
        • Principal Investigator:
          • Nicolas Marcoux, MD, FRCPC
      • Québec, Quebec, Canada
        • Not yet recruiting
        • Institut universitaire de Cardiologie et de Pneumologie de Quebec
        • Contact:
        • Principal Investigator:
          • Philippe Joubert, MD, PhD
      • Sherbrooke, Quebec, Canada
        • Recruiting
        • Centre hospitalier universitaire de Sherbrooke (CHUS)
        • Principal Investigator:
          • Nicole Bouchard, MD
        • Contact:
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Not yet recruiting
        • Allan Blair Cancer Centre
        • Contact:
        • Principal Investigator:
          • Ayesha Bashir, MD, FRCPC
      • Saskatoon, Saskatchewan, Canada
        • Not yet recruiting
        • Saskatoon Cancer Centre
        • Contact:
        • Principal Investigator:
          • Sunil Yadav, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Progression Free Survival [PFS] or Overall Survival [OS]
Time Frame: From the start date of cancer therapy until the date of first documented progression or date of death (any cause), assessed up to 120 months
Composite of disease progression or death
From the start date of cancer therapy until the date of first documented progression or date of death (any cause), assessed up to 120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain metastasis/other metastatic tumours
Time Frame: From the start date of cancer therapy until the date of first documented brain/other metastasis, assessed up to 120 months
Confirmed through imaging (MRI, CT) or determined through treatment indication(s), for example, brain radiation therapy (surrogate for presence of brain metastasis)
From the start date of cancer therapy until the date of first documented brain/other metastasis, assessed up to 120 months
EORTC quality of life questionnaires (QLQ) - cancer patient-reported health related quality of life
Time Frame: Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
Prospectively enrolled participants will complete the following health related quality of life surveys: EORTC QLQ-C30 (core) and EORTC QLQ-LC13 (disease specific module)
Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
EQ-5D-5L - patient-reported health related quality of life measure
Time Frame: Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
Prospectively enrolled participants will complete the health related quality of life survey: EQ-5D-5L.
Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
Patient-reported economic impact
Time Frame: Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
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.
Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Bayer
AstraZeneca
Amgen
Applied Health Research Centre
Nuvation Bio Inc.
Takeda Canada, Inc.
Programs for Assessment of Technology in Health Research Institute
IQVIA Solutions Canada Inc.

Investigators

  • Principal Investigator: Geoffrey Liu, MD, MSc, Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2020

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARMA-BROS
  • 18-5902 (Other Identifier: CAPCR-University Health Network)
  • 1632 (Other Identifier: Clinical Trials Ontario (CTO)-Ontario Cancer Research Ethics Board (OCREB))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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