Pan-Canadian Lung Cancer Observational Study (PALEOS)

Lung Cancer Clinical Trial

Official title:

Pan-Canadian Lung Cancer Observational Study (PALEOS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04706754
• Other study ID #: PALEOS
• Status: Recruiting
• Start date: April 7, 2020
• Est. completion date: April 7, 2045

Study information

• Verified date: June 2022
• Source: William Osler Health System
• Contact: Lynn Vicente
• Phone: 4164362556
• Email: lynn.vicente[@]williamoslerhs.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Questionnaires
Prospectively enrolled participants will be provided with survey packets comprised of different questionnaires at the initial/baseline visit and every 3 months and/or whenever there is an update in their treatment protocol

Locations

Country	Name	City	State
Canada	Milena (Lynn) Vicente	Brampton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
William Osler Health System	Pulse InfoFrame

Country where clinical trial is conducted

Canada, 

Outcome

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