CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS) (CARMA-BROS)
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| ClinicalTrials.gov Identifier: NCT04151342 |
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Recruitment Status :
Recruiting
First Posted : November 5, 2019
Last Update Posted : November 21, 2022
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Sponsor:
University Health Network, Toronto
Collaborators:
Takeda Canada, Inc.
Applied Health Research Centre
Programs for Assessment of Technology in Health Research Institute
AstraZeneca
Amgen
Information provided by (Responsible Party):
University Health Network, Toronto
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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, and BRAF, 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.
| Condition or disease | Intervention/treatment |
|---|---|
| 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 | Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents. Other: Patient-reported outcomes (PROs) |
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:
- 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.
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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:
- 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.
- 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.
- To assess quality of life in patients with rare molecular alterations across different stages, lines and types of therapy.
- To perform exploratory health economic evaluations focused on the costs and benefits of managing patients with rare molecular alterations.
- To perform biomarker analyses, where appropriate, to improve our understanding of these rare molecular alterations.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | CAnadian CAncers With Rare Molecular Alterations (CARMA) - Basket Real-world Observational Study (BROS) |
| Actual Study Start Date : | January 17, 2020 |
| Estimated Primary Completion Date : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Tyrosine
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
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Comparator group
All cancer patients without rare molecular alterations in their 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.
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Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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)
- 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)
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151342
Contacts
| Contact: Roula Raptis, MSc | 416-864-6060 ext 47106 | Roula.Raptis@unityhealth.to | |
| Contact: Geoffrey Liu, MD, MSc | 416-946-4501 ext 3428 | Geoffrey.Liu@uhn.ca |
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre - University of Calgary - Alberta Health Services | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Winson Cheung, MD, MPH, FRCPC | |
| Cross Cancer Institute, University of Alberta - Alberta Health Services | Not yet recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Quincy Siu-Chung Chu, MD, FRCPC | |
| Canada, Manitoba | |
| CancerCare Manitoba/University of Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Shantanu Banerji, MD, FRCPC | |
| Canada, Nova Scotia | |
| Queen Elizabeth II (QEII) Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Stephanie Snow, MD, FRCPC | |
| Canada, Ontario | |
| William Osler Health System - Brampton Civic Hospital | Recruiting |
| Brampton, Ontario, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Parneet Cheema, MD, FRCPC | |
| Hamilton Health Sciences - Juravinski Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Rosalyn Juergens, MD, PhD | |
| Kingston Health Sciences Centre (KHSC) | Not yet recruiting |
| Kingston, Ontario, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Andrea Fung, MD, PhD, FRCPC | |
| Lawson Health Research Institute - London Health Sciences Centre | Recruiting |
| London, Ontario, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Sara Kuruvilla, MD, FRCPC | |
| Ottawa Hospital Cancer Centre | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Paul Wheatley-Price, MBChB, FRCP(UK), MD | |
| Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN) | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Devalben Patel, BSc, MLT 416-581-7447 Devalben.Patel@uhn.ca | |
| Principal Investigator: Geoffrey Liu, MD, MSc | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Ronald Burkes, MD, FRCPC | |
| Canada, Quebec | |
| Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting |
| Montréal, Quebec, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Normand Blais, MD, MSc | |
| Hôpital du Sacré-Coeur-de-Montréal (HSCM) | Not yet recruiting |
| Montréal, Quebec, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Kevin Jao, MD, PhD | |
| Jewish General Hospital | Recruiting |
| Montréal, Quebec, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Jason Agulnik, MD | |
| Centre hospitalier universitaire de Sherbrooke (CHUS) | Recruiting |
| Sherbrooke, Quebec, Canada | |
| Contact: Roula Raptis, MSc Roula.Raptis@unityhealth.to | |
| Principal Investigator: Nicole Bouchard, MD | |
Sponsors and Collaborators
University Health Network, Toronto
Takeda Canada, Inc.
Applied Health Research Centre
Programs for Assessment of Technology in Health Research Institute
AstraZeneca
Amgen
Investigators
| Principal Investigator: | Geoffrey Liu, MD, MSc | Princess Margaret Cancer Centre |
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT04151342 |
| 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) ) |
| First Posted: | November 5, 2019 Key Record Dates |
| Last Update Posted: | November 21, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Health Network, Toronto:
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observational study cancer cancer therapies molecular alterations real-world evidence |
real-world data tyrosine kinase inhibitors ambispective ras GTPase inhibitors |
Additional relevant MeSH terms:
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Neoplasms, Second Primary Neoplasms Tyrosine Protein Kinase Inhibitors |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |