Ignite Creation Date:
2024-05-06 @ 1:53 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04151342
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2019-10-29
Brief Title:
CAnadian CAncers With Rare Molecular Alterations CARMA - Basket Real-world Observational Study BROS
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
CAnadian CAncers With Rare Molecular Alterations CARMA - Basket Real-world Observational Study BROS
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARMA-BROS
Brief Summary:
This study will collect data on Canadian cancer patients that have uncommonrare changes in their tumours such as alterationsrearrangements 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-5902 | OTHER | None | None |
| 1632 | OTHER | Clinical Trials Ontario CTO-Ontario Cancer Research Ethics Board OCREB | None |