Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04706754
Status:
RECRUITING
Last Update Posted:
2022-06-22
First Post:
2020-05-20
Brief Title:
Pan-Canadian Lung Cancer Observational Study PALEOS
Sponsor:
William Osler Health System
Organization:
William Osler Health System
Study Overview
Official Title:
Pan-Canadian Lung Cancer Observational Study PALEOS
Status:
RECRUITING
Status Verified Date:
2022-06
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:
None
Brief Summary:
This study is a multicenter ambispective observational study that will collect data focusing on patients with lung cancers in Canada The study will begin with ALK EGFR ROS1 ERBB2 HER2 exon 20 EGFR mutation MET and BRAF patients with the goal of expanding into other rare molecular alterations within year 2
Detailed Description:
Lung cancer is no longer considered a single entity In the new world of lung cancer it consists of many subgroups that are defined in different ways by different clinicians and researchers In broad categories these include sociodemographic molecular treatment or biomarker-driven subgroups to name a few As a result the single-center study of lung cancer is not viable as no single center has adequate numbers of each subgroup to study by themselves PALEOS is designed to use the power of a multi-institutional study to evaluate these important questions of natural history treatment patterns outcomes as they relate to new diagnostic new biomarkers and new treatments Real-world data will be generated by PALEOS Thus there will be a broader understanding of how treatments and outcomes that were originally studied in the clinical trial setting would now be translated into the real-world setting
Primary Study Objectives
1 To report on the natural history of multiple subgroups of lung cancer patients regardless of stage in Canada from 2006 onwards using a combination of retrospective and prospective methods that includes diagnostic molecular alterations treatment and outcomes
2 To report the real-world treatment patterns of all and specific subgroups of lung cancer patients in Canada across time from 2006 onwards geography
3 To recruit from centers that are representative of Canadian patients seen in both academic and community cancer settings
Secondary Study Objectives
1 To evaluate patient-reported outcomes of different subgroups of lung cancer through all phases of the disease from diagnosis through to end-of-life
2 To understand the incidence prevalence and outcomes efficacy and toxicity and patterns of locoregional and metastatic spread of different subgroups of lung cancer
3 To understand the evolution of clinical implementation of new diagnostic tests new biomarker tests new treatments whether it be surgical medical radiation or other including access by healthcare teams and patients their rates of adoption into clinical practice and retention of overtime
4 To develop economic models for various subgroups of lung cancer patients based on the accumulated data within the PALEOS study
5 To compare the natural history stage distribution treatment outcomes such as treatment effectiveness composite of disease progression or death and treatment toxicities where available across sub-group of patients with tumors that have been molecularly subtyped and identified to have rare molecular alterations
Primary Study Objectives
1 To report on the natural history of multiple subgroups of lung cancer patients regardless of stage in Canada from 2006 onwards using a combination of retrospective and prospective methods that includes diagnostic molecular alterations treatment and outcomes
2 To report the real-world treatment patterns of all and specific subgroups of lung cancer patients in Canada across time from 2006 onwards geography
3 To recruit from centers that are representative of Canadian patients seen in both academic and community cancer settings
Secondary Study Objectives
1 To evaluate patient-reported outcomes of different subgroups of lung cancer through all phases of the disease from diagnosis through to end-of-life
2 To understand the incidence prevalence and outcomes efficacy and toxicity and patterns of locoregional and metastatic spread of different subgroups of lung cancer
3 To understand the evolution of clinical implementation of new diagnostic tests new biomarker tests new treatments whether it be surgical medical radiation or other including access by healthcare teams and patients their rates of adoption into clinical practice and retention of overtime
4 To develop economic models for various subgroups of lung cancer patients based on the accumulated data within the PALEOS study
5 To compare the natural history stage distribution treatment outcomes such as treatment effectiveness composite of disease progression or death and treatment toxicities where available across sub-group of patients with tumors that have been molecularly subtyped and identified to have 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