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Pan-Canadian Lung Cancer Observational Study (PALEOS)

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ClinicalTrials.gov Identifier: NCT04706754
Recruitment Status : Recruiting
First Posted : January 13, 2021
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
Pulse InfoFrame
Information provided by (Responsible Party):
Dr. Parneet Cheema, William Osler Health System

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

Condition or disease Intervention/treatment
Lung Cancer 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Pan-Canadian Lung Cancer Observational Study (PALEOS)
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : April 7, 2040
Estimated Study Completion Date : April 7, 2045

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Treatment effectiveness [ Time Frame: Patients will be followed for at least 5 years, for a total of 25 years ]

    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


  2. Outcome of Patients [ Time Frame: Patients will be followed for at least 5 years, for a total of 25 years ]

    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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04706754


Contacts
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Contact: Lisa Faure 9054942120 ext 58389 Lisa.Faure@williamoslerhs.ca

Locations
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Canada, Ontario
William Osler Health System - Brampton Civic Hospital Recruiting
Brampton, Ontario, Canada, L6R 3J7
Contact: Karan Singh    905 494 2120 ext 50909    Karan.Singh@williamoslerhs.ca   
Contact: Deepanjali Kaushik    905 494 2120 ext 50909    Deepanjali.Kaushik@williamoslerhs.ca   
Principal Investigator: Parneet Cheema, MD         
Sponsors and Collaborators
William Osler Health System
Pulse InfoFrame
Investigators
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Principal Investigator: Parneet Cheema, MD William Osler Health System
Principal Investigator: Sara Kuruvilla, MD London Health Science Center
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Responsible Party: Dr. Parneet Cheema, Principal Investigator, William Osler Health System
ClinicalTrials.gov Identifier: NCT04706754    
Other Study ID Numbers: PALEOS
First Posted: January 13, 2021    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases