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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04151342
Other study ID # CARMA-BROS
Secondary ID 18-59021632
Status Recruiting
Phase
First received
Last updated
Start date January 17, 2020
Est. completion date December 2025

Study information

Verified date May 2024
Source University Health Network, Toronto
Contact Roula Raptis, MSc
Phone 416-864-6060
Email Roula.Raptis@unityhealth.to
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Canada William Osler Health System - Brampton Civic Hospital Brampton Ontario
Canada Tom Baker Cancer Centre - University of Calgary - Alberta Health Services Calgary Alberta
Canada Cross Cancer Institute, University of Alberta - Alberta Health Services Edmonton Alberta
Canada Dr. Everett Chalmers Regional Hospital Fredericton New Brunswick
Canada Queen Elizabeth II (QEII) Health Sciences Centre Halifax Nova Scotia
Canada Hamilton Health Sciences - Juravinski Cancer Centre Hamilton Ontario
Canada Kingston Health Sciences Centre (KHSC) Kingston Ontario
Canada Lawson Health Research Institute - London Health Sciences Centre London Ontario
Canada Centre hospitalier de l'Université de Montréal (CHUM) Montréal Quebec
Canada Hôpital du Sacré-Coeur-de-Montréal (HSCM) Montréal Quebec
Canada Jewish General Hospital Montréal Quebec
Canada McGill University Health Centre Montréal Quebec
Canada St. Mary's Hospital Center Montréal Quebec
Canada Ottawa Hospital Cancer Centre Ottawa Ontario
Canada Centre hospitalier de l'université de Québec - Université Laval Québec City Quebec
Canada Institut Universitaire de Cardiologie et de Pneumologie de Québec Québec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Dr. H. Bliss Murphy Cancer Centre Saint John's Newfoundland and Labrador
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Centre hospitalier universitaire de Sherbrooke (CHUS) Sherbrooke Quebec
Canada Health Sciences North Sudbury Ontario
Canada Thunder Bay Regional Health Sciences Centre Thunder Bay Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN) Toronto Ontario
Canada Sunnybrook Research Institute - Sunnybrook Health Sciences Centre Toronto Ontario
Canada BC Cancer Vancouver British Columbia
Canada CancerCare Manitoba/University of Manitoba Winnipeg Manitoba

Sponsors (8)

Lead Sponsor Collaborator
University Health Network, Toronto Amgen, AnHeart Therapeutics Inc., Applied Health Research Centre, AstraZeneca, Bayer, Programs for Assessment of Technology in Health Research Institute, Takeda Canada, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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) From the start date of cancer therapy until the date of first documented brain/other metastasis, assessed up to 120 months
Secondary 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) Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
Secondary 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. Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
Secondary 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. Baseline and serial changes every 3 months, including whenever there is a change in treatment, up to 120 months (the duration of this study)
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