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Clinical Trials/NCT05452200
NCT05452200RecruitingNot Applicable

Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital

Hospices Civils de Lyon4 sites in 1 country600 target enrollmentStarted: September 21, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
600
Locations
4
Primary Endpoint
Participation rate at baseline

Study Overview

Brief Summary

Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.

In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.

The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.

ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.

This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Participation rate at baseline

Time Frame: At the baseline visit

Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees

Secondary Outcomes

  • Evaluate the participation rate at 1 year and identify the factors that trigger it.(At 1Year follow-up)
  • Evaluation of the efficiency of VOC for LC screening(At baseline)
  • Participation rate according to the 3 communication levels.(At 4 month = level 1 ; At 8 month = level 2 ; At 12 month = level 3)
  • Evaluation of feasibility of the LCS program by measuring the proportion of individuals having undergo all the required exams and evaluations according to the results of the CT scan, conformity of the scan interpretation, and adverse event monitoring.(At baseline and At 1Year follow-up)
  • Identification of efficient biomarker for LC screening(At baseline)
  • Identification of predictive factors for participation decision(At baseline and At 1Year follow-up)
  • Evaluation of screening efficiency according to the proportion of lung cancer, ILD, COPD diagnosed and the percentage of smoking cessation among the active smokers.(At baseline and At 1Year follow-up)
  • Evaluate the follow up to the french guidelines(Follow up after the 1 year visit)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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