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

NCT04151342 | Recruiting

• 3 other identifiers: CARMA-BROS18-59021632
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 27

Brief 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

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

Keywords

observational study; cancer; cancer therapies; molecular alterations; real-world evidence; real-world data; tyrosine kinase inhibitors; ambispective; ras GTPase inhibitors

Outcome Measures

Primary Outcomes (1)

• Composite of Progression Free Survival [PFS] or Overall Survival [OS]

  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 Outcomes (4)

• Brain metastasis/other metastatic tumours

  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

  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

  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

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

Study Arms (3)

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.; Other: Patient-reported outcomes (PROs)

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.

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.

Interventions

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.

Prospective

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.

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Takeda Canada, Inc.: collaborator
• University Health Network, Toronto: lead
• 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

Study Sites (27)

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

Calgary, Alberta, Canada

RECRUITING

Cross Cancer Institute, University of Alberta - Alberta Health Services

Edmonton, Alberta, Canada

NOT YET RECRUITING

BC Cancer

Vancouver, British Columbia, Canada

RECRUITING

CancerCare Manitoba/University of Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick, Canada

RECRUITING

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

NOT YET RECRUITING

Queen Elizabeth II (QEII) Health Sciences Centre

Halifax, Nova Scotia, Canada

RECRUITING

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, Canada

RECRUITING

Health Sciences North

Greater Sudbury, Ontario, Canada

RECRUITING

Hamilton Health Sciences - Juravinski Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

Kingston Health Sciences Centre (KHSC)

Kingston, Ontario, Canada

RECRUITING

Lawson Health Research Institute - London Health Sciences Centre

London, Ontario, Canada

RECRUITING

Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

RECRUITING

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

NOT YET RECRUITING

Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN)

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

Sunnybrook Research Institute - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

RECRUITING

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

Montreal, Quebec, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

NOT YET RECRUITING

St. Mary's Hospital Center

Montreal, Quebec, Canada

NOT YET RECRUITING

Centre hospitalier de l'université de Québec - Université Laval

Québec, Quebec, Canada

NOT YET RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, Canada

NOT YET RECRUITING

Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

NOT YET RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasms, Second Primary; Congenital Abnormalities

Interventions

Tyrosine Kinase Inhibitors; Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Geoffrey Liu, MD, MSc

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faisal Al-Agha, BSc

CONTACT

416-946-4501; faisal.al-agha@uhn.ca

Roula Raptis, MSc

CONTACT

416-864-6060; Roula.Raptis@unityhealth.to

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 5, 2019
• Study Start: January 17, 2020
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

CA (27)