Lung CancerNCT05645731
Lung Cancer Screening in Family Members and Peers of Lung Cancer Patients: a Prospective Cohort Study
An observational study of Lung Cancer and Lung Cancer Screening, run by Nicole Ezer, MD, FRCPC, MPH at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Lung Cancer Screening, Patient Empowerment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 12 May 2023to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Lung cancer patient recruited at clinics at the MUHC. 2. Close contacts of lung cancer patients referred to our study
Who may be able to join
- > 18 years old
- Current or former lung cancer patient
Who cannot join
- Referred participants Inclusion criteria: >18 years old Exclusion criteria: Personal history of lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lung Cancer, Lung Cancer Screening, Patient Empowerment
- Medical subject headings
- Lung Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks post inclusion
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.
Measured: baseline
Secondary outcomes (9)
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.
Measured: 6 months
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.
Measured: 6 months
Number of referred participants who enrolled in the study.
Number of referred participants who enrolled in the study.
Measured: 6 months
PLCO score as a binary outcome (above or below 2%) among referred participants
Measured: baseline
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
Measured: 18 months
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.
Measured: baseline
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
Measured: baseline
Anxiety regarding lung cancer for referred participants
GAD7
Measured: baseline
Anxiety regarding lung cancer for referred participants
GAD7
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start12 May 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole Ezer, MD, FRCPC, MPH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole Ezer, MD, FRCPC, MPH, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Nicole Ezer, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645731
- Sponsor's protocol ID
- MP-37-2023-9041
- Status last verified
- Aug 2025
- First submitted
- 1 Dec 2022
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pitrou I, Petrangelo A, Besson C, Pepe C, Waschke AH, Agulnik J, Gonzalez AV, Ezer N. Lung Cancer Screening in Family Members and Peers of Patients With Lung Cancer: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Mar 28;14:e58529. doi: 10.2196/58529.
PubMed 40153794
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Screening in Family Members and Peers of Lung Cancer Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05645731
- Acronym / sponsor ID
- MP-37-2023-9041
- Conditions
- Lung Cancer, Lung Cancer Screening, Patient Empowerment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nicole Ezer, MD, FRCPC, MPHUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Lung cancer patient recruited at clinics at the MUHC. 2. Close contacts of lung cancer patients referred to our study
Key inclusion criteria (2 listed)
- > 18 years old
- Current or former lung cancer patient
Key exclusion criteria (1 listed)
- Referred participants Inclusion criteria: >18 years old Exclusion criteria: Personal history of lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
9 secondary outcomes
Number of visitors on our website for referred participants
Time frame: 6 months
Number of people who started to fill the enrollment form for referred participants.
Time frame: 6 months
Number of referred participants who enrolled in the study.
Time frame: 6 months
PLCO score as a binary outcome (above or below 2%) among referred participants
Time frame: 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 individuals who would theoretically demonstrate interest in genetic testing to assess for lung cancer risk.
Time frame: baseline
Proportion of individuals who demonstrate interest in referral to a smoking cessation program among referred participants that are current smokers
Time frame: baseline
Anxiety regarding lung cancer for referred participants
Time frame: baseline
Anxiety regarding lung cancer for referred participants
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 40153794Pitrou I, Petrangelo A, Besson C, Pepe C, Waschke AH, Agulnik J, Gonzalez AV, Ezer N. Lung Cancer Screening in Family Members and Peers of Patients With Lung Cancer: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Mar 28;14:e58529. doi: 10.2196/58529.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Ezer, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Lung Cancer Screening, run by Nicole Ezer, MD, FRCPC, MPH at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of referrals for lung cancer screening per participants (time frame: 2 weeks post inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.