High-Risk CancerDECANPHARNCT06020443
Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.
A study testing Low Dose chest CT Scan for Lung Cancer Screening in people with High-Risk Cancer and Lung Cancer, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial summary
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- High-Risk Cancer, Lung Cancer
- What is being tested?
- Low Dose chest CT Scan for Lung Cancer Screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to measure adherence to a lung cancer screening program using low-dose thoracic CT.
Read the 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.
- Conditions
- High-Risk Cancer, Lung Cancer
- Being tested
- Low Dose chest CT Scan for Lung Cancer Screening
- Keywords
- screening, low dose chest computed tomography, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose chest CT Scan for Lung Cancer ScreeningProcedure or surgery
Low dose CT scans will be performed for three years
| Study group | Role | What they receive |
|---|---|---|
| Patients with a high risk of lung cancer | Other | Not described Receives: Procedure: Low Dose chest CT Scan for Lung Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of included patients having undergone the first screening scan
Measured: T0
Secondary outcomes (7)
Rate of patients who refused to participate in the screening program
Measured: 1 year
Rate of included patients having completed CT scans at each stage of follow-up
Measured: 3 years
Number of patients newly committed to smoking cessation during the screening period
Measured: 3 years
Tobacco consumption
Measured: 3 years
Radiation doses received at each CT scan
Measured: 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
Measured: 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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start6 Nov 2023
- Primary completion5 Nov 2024
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-Risk CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low Dose chest CT Scan for Lung Cancer Screening
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Strentz, MD, Principal investigator, General Practioner, Colmar, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020443
- Sponsor's protocol ID
- GHRMSA 1303
- Other IDs
- 2023-A00803-42
- Acronym
- DECANPHAR
- Status last verified
- May 2026
- First submitted
- 28 Aug 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 May;43(1):87-95. doi: 10.1016/j.rmr.2026.01.002. Epub 2026 Mar 12. French.
PubMed 41826137
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Lung Cancer Screening by Low-dose Thoracic CT in Haut-Rhin Department, France.
- ClinicalTrials.gov ID
- NCT06020443
- Acronym / sponsor ID
- DECANPHAR / GHRMSA 1303
- Conditions
- High-Risk Cancer, Lung Cancer
- Keywords
- screening, low dose chest computed tomography, lung cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 5 Nov 2024 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low Dose chest CT Scan for Lung Cancer Screening
| Arm | Type | Receives |
|---|---|---|
| Patients with a high risk of lung cancer | Other | Procedure: Low Dose chest CT Scan for Lung Cancer Screening |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Dose chest CT Scan for Lung Cancer ScreeningLow dose CT scans will be performed for three years | Procedure or surgery | Patients with a high risk of lung cancer |
Primary outcome
Rate of included patients having undergone the first screening scan
Time frame: T0
7 secondary outcomes
Rate of patients who refused to participate in the screening program
Time frame: 1 year
Rate of included patients having completed CT scans at each stage of follow-up
Time frame: 3 years
Number of patients newly committed to smoking cessation during the screening period
Time frame: 3 years
Tobacco consumption
Time frame: 3 years
Radiation doses received at each CT scan
Time frame: 3 years
Organizational constraints of the screening program
Time frame: before starting the study
Stage at diagnosis (TNM classification) of patients with lung cancer
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 41826137Strentz 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 May;43(1):87-95. doi: 10.1016/j.rmr.2026.01.002. Epub 2026 Mar 12. French.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Strentz, MD principal investigator
General Practioner, Colmar, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Dose chest CT Scan for Lung Cancer Screening in people with High-Risk Cancer and Lung Cancer, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of included patients having undergone the first screening scan (time frame: T0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06020443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.