AzTrials
AzTrials

CancerCARMA-BROSNCT04151342

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

An observational study of Cancer and Malignancies Multiple, run by University Health Network, Toronto at 27 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents. and Patient-reported outcomes (PROs)
How many people
5,500 participants
Where
27 sitesCanada
Study dates
17 Jan 2020to Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

27 sites in 1 country

Canada27 sites, 27 recruiting
  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Parneet Cheema, MD, FRCPC

    Recruiting
  • Tom Baker Cancer Centre - University of Calgary - Alberta Health Services

    Calgary, Alberta

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Vishal Navani, MA (Oxon), MBBS, MRCP, FRACP

    Recruiting
  • Cross Cancer Institute, University of Alberta - Alberta Health Services

    Edmonton, Alberta

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Quincy Siu-Chung Chu, MD, FRCPC

    Not yet recruiting
  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Luisa Galvis-Gomez, MD

    Recruiting
  • Health Sciences North

    Greater Sudbury, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Abhenil Mittal, MD

    Recruiting
  • Queen Elizabeth II (QEII) Health Sciences Centre

    Halifax, Nova Scotia

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Stephanie Snow, MD, FRCPC

    Recruiting
  • Hamilton Health Sciences - Juravinski Cancer Centre

    Hamilton, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Rosalyn Juergens, MD, PhD

    Recruiting
  • Kingston Health Sciences Centre (KHSC)

    Kingston, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Sofia Genta, MD

    Recruiting
  • Lawson Health Research Institute - London Health Sciences Centre

    London, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Sara Kuruvilla, MD, FRCPC

    Recruiting
  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Normand Blais, MD, MSc

    Recruiting
  • Hôpital du Sacré-Coeur-de-Montréal (HSCM)

    Montreal, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Kevin Jao, MD, PhD

    Recruiting
  • Jewish General Hospital

    Montreal, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Jason Agulnik, MD

    Recruiting
  • McGill University Health Centre

    Montreal, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Jonathan Spicer, MD, PhD

    Not yet recruiting
  • St. Mary's Hospital Center

    Montreal, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Nicholas Meti, MD

    Not yet recruiting
  • Ottawa Hospital Cancer Centre

    Ottawa, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Paul Wheatley-Price, MBChB, FRCP(UK), MD

    Recruiting
  • Centre hospitalier de l'université de Québec - Université Laval

    Québec, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Nicolas Marcoux, MD, FRCPC

    Not yet recruiting
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

    Québec, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Philippe Joubert, MD, PhD

    Not yet recruiting
  • Allan Blair Cancer Centre

    Regina, Saskatchewan

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Ayesha Bashir, MD, FRCPC

    Not yet recruiting
  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Sunil Yadav, MD

    Not yet recruiting
  • Centre hospitalier universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Nicole Bouchard, MD

    Recruiting
  • Dr. H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Elizabeth Faour, MD

    Not yet recruiting
  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Olexiy Aseyev, MD

    Not yet recruiting
  • Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN)

    Toronto, Ontario, M5G 2M9

    Faisal Al-Agha, BSc, 416-946-4501 ext. 3428, faisal.al-agha@uhn.ca

    Geoffrey Liu, MD, MSc

    Recruiting
  • Mount Sinai Hospital

    Toronto, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Ronald Burkes, MD, FRCPC

    Recruiting
  • Sunnybrook Research Institute - Sunnybrook Health Sciences Centre

    Toronto, Ontario

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Ines Menjak, MD, FRCPC

    Recruiting
  • BC Cancer

    Vancouver, British Columbia

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Cheryl Ho, MD, FRCPC

    Recruiting
  • CancerCare Manitoba/University of Manitoba

    Winnipeg, Manitoba

    Roula Raptis, MSc, Roula.Raptis@unityhealth.to

    Shantanu Banerji, MD, FRCPC

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.
Being tested
Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents., Patient-reported outcomes (PROs)
Keywords
observational study, cancer, cancer therapies, molecular alterations, real-world evidence, real-world data, tyrosine kinase inhibitors, ambispective, ras GTPase inhibitors
Medical subject headings
Neoplasms, Neoplasms, Second Primary, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.Drug

    Observing 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

    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.

Study groups in NCT04151342
Study groupRoleWhat they receive
ProspectiveLiving 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.
Receives: Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.; Other: Patient-reported outcomes (PROs)
RetrospectiveDeceased 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.
Receives: Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.
Comparator groupAll 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite of Progression Free Survival [PFS] or Overall Survival [OS]

    Composite of disease progression or death

    Measured: 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 outcomes (4)
  1. 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)

    Measured: From the start date of cancer therapy until the date of first documented brain/other metastasis, assessed up to 120 months

  2. 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)

    Measured: Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)

  3. 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.

    Measured: Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)

  4. 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.

    Measured: Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start17 Jan 2020
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
5,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151342
Sponsor's protocol ID
CARMA-BROS
Other IDs
18-5902, 1632
Acronym
CARMA-BROS
Status last verified
Nov 2025
First submitted
29 Oct 2019
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer and Malignancies Multiple, run by University Health Network, Toronto at 27 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faisal Al-Agha, BSc (416-946-4501, faisal.al-agha@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in