Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387017
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-04
Brief Title:
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
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOCEPTION
Brief 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 ie 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with lung cancer over 70 of whom were early-stage I or II and could be managed curatively by minimally invasive surgery unpublished results presented at the World Congress Lung cancer in Singapore on September 10 and 11 2023 A case-control study nested in the PREVALUNG cohort compared the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 15000 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 Marseilles 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 2750 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
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 ie 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 15000 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 Marseilles 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 2750 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None