Pan-Canadian Lung Cancer Observational Study (PALEOS)

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

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Questionnaires

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.

• Study Type: Observational
• Enrollment (Anticipated): 25000

Contacts and Locations

• Study Contact: Name: Lynn Vicente; Phone Number: 58389 4164362556; Email: lynn.vicente@williamoslerhs.ca

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • Recruiting
      • Milena (Lynn) Vicente
      • Contact: Lynn Vicente; Phone Number: 50909 4164362556; Email: lynn.vicente@williamoslerhs.ca
      • Contact: Shawna Noy; Phone Number: 50909 905 494 2120; Email: Shawna.Noy2@williamoslerhs.ca
      • Principal Investigator: Parneet Cheema, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Confirmed ALK, EGFR, ROS1, ERBB2 (HER2), exon 20 EGFR mutation, MET and BRAF cancer patients from across participating sites/cancer centers across Canada.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective; Confirmed ALK, EGFR, ROS1, ERBB2 (HER2), exon 20 EGFR mutation, MET and BRAF cancer patients from across participating sites/cancer centers across Canada.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: William Osler Health System
• Collaborators: Pulse InfoFrame
• Investigators: Principal Investigator: Parneet Cheema, MD, William Osler Health System; Principal Investigator: Sara Kuruvilla, MD, London Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Anticipated): April 7, 2040
• Study Completion (Anticipated): April 7, 2045

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 17, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: PALEOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No