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Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France. (DECANPHAR)

Primary Purpose

High-Risk Cancer, Lung Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Dose chest CT Scan for Lung Cancer Screening
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for High-Risk Cancer focused on measuring screening, low dose chest computed tomography, lung cancer

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 50 to 74 years Smoking OR having smoked (withdrawal of <15 years): ≥15 cigarettes/day for ≥25 years OR ≥10 cigarettes/day for ≥30 years Affiliated or beneficiary of a social security scheme Written informed consent Exclusion Criteria: Inability to walk up two flights of stairs without stopping BMI > 35 kg/m² Recent chest CT scan < 1 year Personal history of lung cancer < 5 years or under treatment Personal history of cancer being monitored by chest CT scan Contraindication to lung cancer treatment or diagnostic investigations Current or recent respiratory symptoms immediately suggestive of lung cancer Pregnant or breast-feeding woman Person under court protection, guardianship or curatorship Person deprived of liberty by judicial or administrative decision.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients with a high risk of lung cancer

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rate of included patients having undergone the first screening scan

    Secondary Outcome Measures

    Rate of patients who refused to participate in the screening program
    Rate of included patients having completed CT scans at each stage of follow-up
    Number of patients newly committed to smoking cessation during the screening period
    Tobacco consumption
    Radiation doses received at each CT scan
    Organizational constraints of the screening program
    Organizational constraints of the screening program will be assessed on a subgroup of general practitioners by semi-structured interviews
    Stage at diagnosis (TNM classification) of patients with lung cancer
    The stages at diagnosis of patients with lung cancer included in the study will be compared with those of undetected patients (data from the Haut-Rhin Cancer Registry).

    Full Information

    First Posted
    August 28, 2023
    Last Updated
    August 28, 2023
    Sponsor
    Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06020443
    Brief Title
    Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.
    Acronym
    DECANPHAR
    Official Title
    Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    September 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 To evaluate patient compliance over the entire duration of the screening program To assess patient smoking cessation To describe radiation doses received during CT scans To identify organizational constraints for general practitioners 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 mGy.cm Product Dose Length (i.e. < 1.5 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 his/her 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High-Risk Cancer, Lung Cancer
    Keywords
    screening, low dose chest computed tomography, lung cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Low Dose chest CT Scan for Lung Cancer Screening
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with a high risk of lung cancer
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Low Dose chest CT Scan for Lung Cancer Screening
    Intervention Description
    Low dose CT scans will be performed for three years
    Primary Outcome Measure Information:
    Title
    Rate of included patients having undergone the first screening scan
    Time Frame
    T0
    Secondary Outcome Measure Information:
    Title
    Rate of patients who refused to participate in the screening program
    Time Frame
    1 year
    Title
    Rate of included patients having completed CT scans at each stage of follow-up
    Time Frame
    3 years
    Title
    Number of patients newly committed to smoking cessation during the screening period
    Time Frame
    3 years
    Title
    Tobacco consumption
    Time Frame
    3 years
    Title
    Radiation doses received at each CT scan
    Time Frame
    3 years
    Title
    Organizational constraints of the screening program
    Description
    Organizational constraints of the screening program will be assessed on a subgroup of general practitioners by semi-structured interviews
    Time Frame
    before starting the study
    Title
    Stage at diagnosis (TNM classification) of patients with lung cancer
    Description
    The stages at diagnosis of patients with lung cancer included in the study will be compared with those of undetected patients (data from the Haut-Rhin Cancer Registry).
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 50 to 74 years Smoking OR having smoked (withdrawal of <15 years): ≥15 cigarettes/day for ≥25 years OR ≥10 cigarettes/day for ≥30 years Affiliated or beneficiary of a social security scheme Written informed consent Exclusion Criteria: Inability to walk up two flights of stairs without stopping BMI > 35 kg/m² Recent chest CT scan < 1 year Personal history of lung cancer < 5 years or under treatment Personal history of cancer being monitored by chest CT scan Contraindication to lung cancer treatment or diagnostic investigations Current or recent respiratory symptoms immediately suggestive of lung cancer Pregnant or breast-feeding woman Person under court protection, guardianship or curatorship Person deprived of liberty by judicial or administrative decision.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Didier Debieuvre, MD
    Phone
    +33389647032
    Email
    debieuvred@ghrmsa.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patrick Strentz, MD
    Organizational Affiliation
    General Practioner, Colmar, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.

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