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

May 5, 2026 updated by: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Haut-Rhin
      • Colmar, Haut-Rhin, France, 68000
        • Cabinet de médecine générale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of included patients having undergone the first screening scan
Time Frame: T0
T0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients who refused to participate in the screening program
Time Frame: 1 year
1 year
Rate of included patients having completed CT scans at each stage of follow-up
Time Frame: 3 years
3 years
Number of patients newly committed to smoking cessation during the screening period
Time Frame: 3 years
3 years
Tobacco consumption
Time Frame: 3 years
3 years
Radiation doses received at each CT scan
Time Frame: 3 years
3 years
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
before starting the study
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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Investigators

  • Principal Investigator: Patrick Strentz, MD, General Practioner, Colmar, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Actual)

November 5, 2024

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHRMSA 1303
  • 2023-A00803-42 (Other Identifier: French Health Authority)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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