Quebec Lung Cancer Screening PLUS Trial

NCT ID: NCT05444062

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-23

Study Completion Date

2027-09-30

Brief Summary

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Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months

Detailed Description

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Conditions

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COPD Coronary Artery Calcification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Arm: CVD

Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.

Coronary artery Calcification (CAC) score obtained from lung cancer screening CT Scan images

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm: CVD

Patients diagnosed with mild to severe CAC and not on first line guideline recommended therapy.

CAC score obtained from lung cancer screening CT Scan images

Group Type OTHER

Educational material and treatment recommendations for patients, general practitioners and pharmacists

Intervention Type BEHAVIORAL

Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.

Control Arm: COPD

Patients with untreated COPD or not on first line guideline recommended therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Arm: COPD

Patients with untreated COPD or not on first line guideline recommended therapy.

Group Type OTHER

Educational material and treatment recommendations for patients, general practitioners and pharmacists

Intervention Type BEHAVIORAL

Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.

Interventions

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Educational material and treatment recommendations for patients, general practitioners and pharmacists

Educational material and treatment recommendations given to patients, their family doctors and their pharmacists.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest.
* Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy.
* COPD aim: diagnosed with COPD, symptomatic (mMRC \>=1 or CAT\>= 10) and untreated, or not on first line guideline recommended therapy for COPD.

Exclusion Criteria

* Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies.
* Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus.
* COPD aim: asymptomatic, or already on appropriate first line COPD therapy.
Minimum Eligible Age

55 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicole Ezer, MD, FRCPC, MPH

OTHER

Sponsor Role lead

Responsible Party

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Nicole Ezer, MD, FRCPC, MPH

Assistant professor of medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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McGill University Health Center

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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MP-37-2023-8641

Identifier Type: -

Identifier Source: org_study_id

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