Lung Cancer Screening in Family Members and Peers of Lung Cancer Patients: a Prospective Cohort Study

Sponsor
Nicole Ezer, MD, FRCPC, MPH (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05645731
Collaborator
(none)
100
23

Study Details

Study Description

Brief Summary

Lung cancer screening of active or former heavy smokers with yearly low-dose CT allows for earlier diagnosis and better lung cancer survival. Risk of developing lung cancer is higher among family members and close contacts of lung cancer patients, because of shared genetics, environment and life habits like smoking. The investigators want to engage lung cancer patients to refer their family members and close contacts for lung cancer screening, and evaluate if this referred population have higher risk of lung cancer than the population referred by their family doctors.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Lung Cancer Screening in Family Members and Peers of Lung Cancer Patients: a Prospective Cohort Study
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Lung cancer patient

    Lung cancer patients or lung cancer survivors willing to refer close contacts for lung cancer screening

    Referred participants

    Participants referred to the study by close contacts living with lung cancer.

    Outcome Measures

    Primary Outcome Measures

    1. Mean number of referrals for lung cancer screening per participants [2 weeks post inclusion]

      Mean number of referrals for lung cancer screening per participants: lung cancer participants will refer contacts directly on the REDCap questionnaire at enrollment. They will be contacted a second time 2 weeks after enrollment and asked if they referred additional people in their entourage for lung cancer screening.

    2. Mean PLCOm2012 risk prediction model score among referred participants [baseline]

      Mean risk of developing lung cancer in the next 6 years using the validated PLCOm2012 risk prediction model in smokers or ex-smokers referred participants that are 55 to 74 years old.

    Secondary Outcome Measures

    1. Number of visitors on our website for referred participants [6 months]

      Quantification of people who visited the website for close contacts of lung cancer patients: Number of unique access to website based on google analytics data.

    2. Number of people who started to fill the enrollment form for referred participants. [6 months]

      Number of people who started to fill the enrollment form for referred participants.

    3. Number of referred participants who enrolled in the study. [6 months]

      Number of referred participants who enrolled in the study.

    4. PLCO score as a binary outcome (above or below 2%) among referred participants [baseline]

    5. Proportion of LCS eligible participants who will complete lung cancer screening within 18 months of referral by a lung cancer patient [18 months]

      Proportion of LCS eligible participants who will complete lung cancer screening within 18 months of referral by a lung cancer patient

    6. Proportion of individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk. [baseline]

      Proportion of individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk.

    7. Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers [baseline]

      Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Lung cancer patients:
    Inclusion Criteria:
    • 18 years old

    • Current or former lung cancer patient

    Exclusion Criteria: none

    Referred participants Inclusion criteria: >18 years old Exclusion criteria: Personal history of lung cancer.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nicole Ezer, MD, FRCPC, MPH

    Investigators

    • Principal Investigator: Nicole Ezer, MD, Research Institute of the McGill University Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicole Ezer, MD, FRCPC, MPH, Assistant professor of medicine, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT05645731
    Other Study ID Numbers:
    • MP-37-2023-9041
    First Posted:
    Dec 9, 2022
    Last Update Posted:
    Dec 16, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 16, 2022