Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06387017 |
| Other study ID # |
RCAPHM22_0411 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2024 |
| Est. completion date |
July 2029 |
Study information
| Verified date |
April 2024 |
| Source |
Assistance Publique Hopitaux De Marseille |
| Contact |
Amandine ROLLAND-BRUN |
| Phone |
491381245 |
| Email |
amandine.rolland[@]ap-hm.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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(unpublished results, presented at the World Congress Lung cancer in Singapore on September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.
