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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  1. Lung cancer patient recruited at clinics at the MUHC.
  2. 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nicole Ezer, MD, FRCPC, MPH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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