NCT06387017

Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.

Detailed description

This study aims to validate candidate biomarkers associated with the risk of lung cancer diagnosis among patients with atheromatous disease associated with smoking. hese candidate biomarkers were identified from blood and stool samples taken from the PREVALUNG cohort (NCT03976804), comprising 512 patients with at least one smoking-related atheromatous disease who underwent a thoracic CT lung cancer screening pathway (1 single screening round, i.e. one CT scan and one year of follow-up) at the Marie Lannelongue Hospital - Groupe Hospitalier Paris Saint-Joseph (Le Plessis-Robinson). This screening pathway led to the diagnosis of 14 patients (3%) with lung cancer, over 70% of whom were early-stage (I or II) and could be managed curatively by minimally invasive surgery (unpublished results, presented at the World Congress Lung cancer in Singapore on September 10 and 11, 2023). A case-control study nested in the PREVALUNG cohort compared the biological profiles of patients with suspected lung cancers or nodules with those of patients without lung nodules. Around 15,000 biomarkers per case and control were analyzed by standard statistical methods (descriptive and logistic regression), partial least square method and machine learning after reduction of the number of variables. By analyzing several types of variables linked to inflammation, immunity, blood metabolomics and stool metagenomics, these analyses identified 14 biomarkers divided into 4 groups of candidate biomarkers associated with the diagnosis of lung cancers the second cohort, PREVALUNG ETOILE (NCT05649046), was recruited at Marseille's Hôpital Nord, using the same intervention methods as PREVALUNG, but extending the inclusion criteria to other tobacco-related diseases (atheroma, but also chronic bronchitis and tobacco-related cancers in remission for more than 5 years), to people who would have been eligible in the prospective-randomized studies that have shown that lung cancer screening reduces lung cancer mortality (NLST and NELSON), and to people meeting the criteria of the North American recommendations. The aim of the PREVALUNG ETOILE study is to set up and evaluate a lung cancer screening care pathway at the APHM, using a biological blood and faeces collection identical to that of PREVALUNG. PREVALUNG ETOILE plans to include 160 participants in 2023 (160 have already been included as of September 20, 2023). A 5-month follow-up after the first screening round is planned for each participant. The total number of participants to be included in Europe is 2750. The number of participants to be included in the French BIOCEPTION cohort will therefore be a maximum of 2,750. APHM is coordinating data collection from the various European centers involved in the PREVALUNG BIOCEPTION study. Pr Tatiana Kouznetsova of KU Leuven (Belgium) is in charge of the statistical analysis of the data, in collaboration with APHM. The PREVALUNG BIOCEPTION cohort was set up to validate biomarkers of risk of incident lung cancer at 2 years, as part of screening. These biomarkers will subsequently serve as therapeutic targets for the primary prevention of lung cancer. As part of the PREVALUNG EU project, a prospective randomized 8-arm study is planned to demonstrate the biological effect of drug interventions on the 4 classes of biomarkers that will have been validated (see PREVALUNG EU appendix). This protocol is therefore part of a scientifically validated project funded by the European Commission for the validation of biological biomarkers and the primary prevention of lung cancer risk in patients with smoking-related atheromatous disease. External validation of biomarkers from a cohort of participants at risk of lung cancer without atheromatous disease or moderate or severe calcium score (some participants of PREVALUNG ETOILE or newly recruited) will initiate the extension of the validation and application of these biomarkers to non-atheromatous populations.

Conditions

• Smoking-related Pathology
• Atheroma
• Non-progressive Cancer > 5 Years
• Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood sampling	blood collection
DIAGNOSTIC_TEST	stool collection	stool collection
RADIATION	low dose CT scan	low dose CT scan evaluation

Timeline

• Start date: 2024-04-02
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2024-04-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: France