- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05645731
Lung Cancer Screening in Family Members and Peers of Lung Cancer Patients: a Prospective Cohort Study
August 6, 2025 updated by: Nicole Ezer, MD, FRCPC, MPH
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada
- MUHC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- Lung cancer patient recruited at clinics at the MUHC.
- Close contacts of lung cancer patients referred to our study
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean number of referrals for lung cancer screening per participants
Time Frame: 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 weeks post inclusion
|
|
Mean PLCOm2012 risk prediction model score among referred participants
Time Frame: 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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of visitors on our website for referred participants
Time Frame: 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.
|
6 months
|
|
Number of people who started to fill the enrollment form for referred participants.
Time Frame: 6 months
|
Number of people who started to fill the enrollment form for referred participants.
|
6 months
|
|
Number of referred participants who enrolled in the study.
Time Frame: 6 months
|
Number of referred participants who enrolled in the study.
|
6 months
|
|
PLCO score as a binary outcome (above or below 2%) among referred participants
Time Frame: baseline
|
baseline
|
|
|
Proportion of LCS eligible participants who will complete lung cancer screening within 18 months of referral by a lung cancer patient
Time Frame: 18 months
|
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 individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk.
Time Frame: baseline
|
Proportion of individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk.
|
baseline
|
|
Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers
Time Frame: baseline
|
Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers
|
baseline
|
|
Anxiety regarding lung cancer for referred participants
Time Frame: baseline
|
GAD7
|
baseline
|
|
Anxiety regarding lung cancer for referred participants
Time Frame: 1 month
|
GAD7
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicole Ezer, MD, Research Institute of the McGill University Health Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2023
Primary Completion (Actual)
April 1, 2024
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 8, 2022
First Posted (Actual)
December 9, 2022
Study Record Updates
Last Update Posted (Actual)
August 11, 2025
Last Update Submitted That Met QC Criteria
August 6, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-37-2023-9041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.