Prospective Multicenter Cohort Study for the Development and Evaluation of Risk Stratification Tools for Lung Cancers and Their Postoperative Recurrences Using Multimodal Clinical, Radiological, Tissue and Longitudinal Biological Phenotyping Among People at Risk of Lung Cancer
NCT07042867 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2025-06-29
Summary
Interventional study with minimal risks and constraints, involving annual assessment of the prevalence and incidence of lung cancer using low-dose contrast-free thoracic CT scans, immunological, inflammatory, metabolic, blood nucleic acid and digestive microbiota profiles; systematic proposal of smoking cessation for active smokers, or assistance in maintaining cessation This is a prospective validation study of risk stratification tools still under development.
The results of this study will be used to design medical devices (software integrating risk stratification tools), which will then be evaluated as part of subsequent Clinical Investigations.
Conditions
- Lung Cancer (Diagnosis)
Interventions
- BIOLOGICAL
-
biobanking
blood draw at each time point
- RADIATION
-
low dose scan
low dose lung scan will be performed at each timepoint
Sponsors & Collaborators
-
Assistance Publique Hopitaux De Marseille
lead OTHER
Principal Investigators
-
David Boulate, Professor of Medicine · Assistance Publique Hopitaux De Marseille
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-15
- Primary Completion
- 2028-01-15
- Completion
- 2028-01-15
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