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

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ClinicalTrials.gov Identifier: NCT04151342
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
Takeda Canada, Inc.
Applied Health Research Centre
Programs for Assessment of Technology in Health Research Institute
Information provided by (Responsible Party):
University Health Network, Toronto

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 exon 20, ROS1, and BRAF, which have targeted drugs in a family known as tyrosine kinase inhibitors (TKIs). 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 Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs) Other: Patient-reported outcomes (PROs)

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.

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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 : June 2023
Estimated Study Completion Date : June 2023

Group/Cohort Intervention/treatment
Prospective
Living cancer patients with histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR exon 20, ROS1, and BRAF, from participating sites/cancer centres across Canada.
Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs)
Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) 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 exon 20, ROS1, and BRAF, from participating sites/cancer centres across Canada.
Drug: Cancer treatment with tyrosine kinase inhibitors (TKIs)
Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) for their cancer treatment.

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.



Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. 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)

  3. 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.

  4. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 exon 20, ROS1, BRAF, 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])
  • 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
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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
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Canada, Ontario
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         
Sponsors and Collaborators
University Health Network, Toronto
Takeda Canada, Inc.
Applied Health Research Centre
Programs for Assessment of Technology in Health Research Institute
Investigators
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Principal Investigator: Geoffrey Liu, MD, MSc Princess Margaret Cancer Centre

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04151342    
Other Study ID Numbers: CARMA-BROS
18-5902 ( Other Identifier: CAPCR-University Health Network )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
observational study
cancer
cancer therapies
molecular alterations
real-world evidence
real-world data
tyrosine kinase inhibitors
ambispective
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Neoplasms