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

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: Lung Cancer; High-Risk Cancer
• Intervention / Treatment: Procedure: Low Dose chest CT Scan for Lung Cancer Screening

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	T0

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

General Publications

• Strentz P, Rinaldo F, Jacquet-Pierroulet C, Baumann E, Fonne S, Bizot C, Hammas K, Palpacuer C, Debieuvre D; Decanphar Study Group. [Adherence to lung cancer screening by low-dose chest CT: Results of the first round of screening in the Multicenter Interventional DeCanPHaR Study]. Rev Mal Respir. 2026 Mar 12:S0761-8425(26)00002-1. doi: 10.1016/j.rmr.2026.01.002. Online ahead of print. French.

Study record dates

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: lung cancer; screening; low dose chest computed tomography
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• 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