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

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ClinicalTrials.gov Identifier: NCT06020443
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : November 28, 2023
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Study Description
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Brief Summary:
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.

Condition or disease Intervention/treatment Phase
High-Risk Cancer Lung Cancer Procedure: Low Dose chest CT Scan for Lung Cancer Screening Not Applicable

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Low Dose chest CT Scan for Lung Cancer Screening
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.
Actual Study Start Date : November 6, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Patients with a high risk of lung cancer Procedure: Low Dose chest CT Scan for Lung Cancer Screening
Low dose CT scans will be performed for three years


Outcome Measures
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Primary Outcome Measures :
  1. Rate of included patients having undergone the first screening scan [ Time Frame: T0 ]

Secondary Outcome Measures :
  1. Rate of patients who refused to participate in the screening program [ Time Frame: 1 year ]
  2. Rate of included patients having completed CT scans at each stage of follow-up [ Time Frame: 3 years ]
  3. Number of patients newly committed to smoking cessation during the screening period [ Time Frame: 3 years ]
  4. Tobacco consumption [ Time Frame: 3 years ]
  5. Radiation doses received at each CT scan [ Time Frame: 3 years ]
  6. Organizational constraints of the screening program [ Time Frame: before starting the study ]
    Organizational constraints of the screening program will be assessed on a subgroup of general practitioners by semi-structured interviews

  7. Stage at diagnosis (TNM classification) of patients with lung cancer [ Time Frame: 3 years ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06020443


Contacts
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Contact: Didier Debieuvre, MD +33389647032 debieuvred@ghrmsa.fr

Locations
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France
Cabinet de médecine générale Recruiting
Colmar, Haut-Rhin, France, 68000
Contact: Patrick Strentz         
Sponsors and Collaborators
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Investigators
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Principal Investigator: Patrick Strentz, MD General Practioner, Colmar, France
More Information
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Responsible Party: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
ClinicalTrials.gov Identifier: NCT06020443    
Other Study ID Numbers: GHR 1303
2023-A00803-42 ( Other Identifier: French Health Authority )
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace:
screening
low dose chest computed tomography
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases