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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05645731
Other study ID # MP-37-2023-9041
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 12, 2023
Est. completion date April 2025

Study information

Verified date March 2024
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact Nicole Ezer, MD
Phone (514)-934-1934
Email nicole.ezer@mcgill.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date April 2025
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Canada MUHC Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Nicole Ezer, MD, FRCPC, MPH

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean number of referrals for lung cancer screening per participants 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
Primary Mean PLCOm2012 risk prediction model score among referred participants 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 Number of visitors on our website for referred participants 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
Secondary Number of people who started to fill the enrollment form for referred participants. Number of people who started to fill the enrollment form for referred participants. 6 months
Secondary Number of referred participants who enrolled in the study. Number of referred participants who enrolled in the study. 6 months
Secondary PLCO score as a binary outcome (above or below 2%) among referred participants baseline
Secondary Proportion of LCS eligible participants who will complete lung cancer screening within 18 months of referral by a lung cancer patient Proportion of LCS eligible participants who will complete lung cancer screening within 18 months of referral by a lung cancer patient 18 months
Secondary Proportion of individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk. Proportion of individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk. baseline
Secondary Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers baseline
Secondary Anxiety regarding lung cancer for referred participants GAD7 baseline
Secondary Anxiety regarding lung cancer for referred participants GAD7 1 month
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