Lung Cancer Clinical Trial
Official title:
Pan-Canadian Lung Cancer Observational Study (PALEOS)
NCT number | NCT04706754 |
Other study ID # | PALEOS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 7, 2020 |
Est. completion date | April 7, 2045 |
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
Status | Recruiting |
Enrollment | 25000 |
Est. completion date | April 7, 2045 |
Est. primary completion date | April 7, 2040 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults aged 18 years or older confirmed having lung cancer diagnosis since 2006. - Canadian residents having lung cancer diagnosis with follow-up for cancer care occurring or planned to occur in Canada at the time of enrolment. Exclusion Criteria: - Inability to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Canada | Milena (Lynn) Vicente | Brampton | Ontario |
Lead Sponsor | Collaborator |
---|---|
William Osler Health System | Pulse InfoFrame |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment effectiveness | 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.
To report the real-world treatment patterns of all and specific subgroups of lung cancer patients in Canada, across time (from 2006 onwards), geography. To recruit from centres that are representative of Canadian patients seen in both academic and community cancer settings. Composite of disease progression or death |
Patients will be followed for at least 5 years, for a total of 25 years | |
Primary | Outcome of Patients | To evaluate patient-reported outcomes of different subgroups of lung cancer, through all phases of the disease, from diagnosis through to end-of-life.
To understand the incidence, prevalence, and outcomes (efficacy and toxicity), and patterns of locoregional and metastatic spread of different subgroups of lung cancer. 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 over time. 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. Overall survival (OS) and progression free survival (PFS). |
Patients will be followed for at least 5 years, for a total of 25 years |
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