Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06020443
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-08-28
Brief Title:
Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department France
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study Overview
Official Title:
Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department France
Status:
RECRUITING
Status Verified Date:
2023-11
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:
DECANPHAR
Brief Summary:
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT
Detailed Description:
Secondary objectives
1 To evaluate patient compliance over the entire duration of the screening program
2 To assess patient smoking cessation
3 To describe radiation doses received during CT scans
4 To identify organizational constraints for general practitioners
5 To compare stages at diagnosis before and after implementation of screening program
Conduct of research Eligible patients will be identified by general practitioners Patients included will require a low-dose thoracic CT scan to be performed by a radiologist of their choice Smoking cessation will be systematically proposed and will be carried out by the general practitioner or a tobaccologist
The radiation dose from thoracic CT scans should not exceed 100 mGycm Product Dose Length ie 15 mSv Imaging reports will be forwarded to the general practitioner
If the first CT scan is negative T0 a second scan will be scheduled 1 year later T1 If this second scan is also negative in the absence of lung cancer risk factors other than smoking scans will then be performed every two years In the presence of a risk factor for lung cancer other than tobacco screening will remain annual
In the event of a result classified as uncertain a follow-up scan is scheduled at 3 months if the follow-up scan is negative the next screening will be scheduled 1 year after this follow-up scan If the screening performed 1 year later is also negative subsequent screenings will be performed annually
In the event of a positive result the general practitioner will refer the patient to a pneumologist of hisher choice for further examinations data from these additional examinations will be collected
The screening protocol may evolve in line with recommendations issued by the French National Authority for Health HAS
For participants undergoing CT scan at the imaging department of Emile Muller hospital in Mulhouse GHRMSA a blood sample will be collected optional for subsequent biomarker assays
1 To evaluate patient compliance over the entire duration of the screening program
2 To assess patient smoking cessation
3 To describe radiation doses received during CT scans
4 To identify organizational constraints for general practitioners
5 To compare stages at diagnosis before and after implementation of screening program
Conduct of research Eligible patients will be identified by general practitioners Patients included will require a low-dose thoracic CT scan to be performed by a radiologist of their choice Smoking cessation will be systematically proposed and will be carried out by the general practitioner or a tobaccologist
The radiation dose from thoracic CT scans should not exceed 100 mGycm Product Dose Length ie 15 mSv Imaging reports will be forwarded to the general practitioner
If the first CT scan is negative T0 a second scan will be scheduled 1 year later T1 If this second scan is also negative in the absence of lung cancer risk factors other than smoking scans will then be performed every two years In the presence of a risk factor for lung cancer other than tobacco screening will remain annual
In the event of a result classified as uncertain a follow-up scan is scheduled at 3 months if the follow-up scan is negative the next screening will be scheduled 1 year after this follow-up scan If the screening performed 1 year later is also negative subsequent screenings will be performed annually
In the event of a positive result the general practitioner will refer the patient to a pneumologist of hisher choice for further examinations data from these additional examinations will be collected
The screening protocol may evolve in line with recommendations issued by the French National Authority for Health HAS
For participants undergoing CT scan at the imaging department of Emile Muller hospital in Mulhouse GHRMSA a blood sample will be collected optional for subsequent biomarker assays
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00803-42 | OTHER | French Health Authority | None |