Bronchopulmonary DiseaseOPTI-DEPISTNCT06439901
Optimizing Bronchopulmonary Cancer Screening
A study testing Screening, Inclusion and Chest CTscan and follow-up in people with Bronchopulmonary Disease and Diagnoses Disease, run by Institut Curie at 9 sites in France.
Trial summary
The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Bronchopulmonary Disease, Diagnoses Disease
- What is being tested?
- Screening, Inclusion and Chest CTscan and follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 9 sitesFrance
- Study dates
- 27 Jan 2025to 5 Feb 2034
- 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
- Participant aged 50 to 74.
- Resident in the Île-de-France region.
- Active smoker or quit smoker for 10 years or less:
- more than 10 cigarettes a day for more than 30 years,
- more than 15 cigarettes a day for more than 25 years.
- The participant has been informed and has signed the consent form.
- Social Security System affiliation.
- Willingness to participate in a smoking cessation program, if currently smoking.
Who cannot join
- Active cancer or a history of cancer in remission for less than 5 years (except basal cell carcinoma of th skin or epithelioma in situ of the uterine cervix).
- Presence of symptoms suggestive of bronchopulmonary cancer. Participants with these symptoms require immediate diagnostic investigations and are therefore not eligible for screening.
- Weight >= 140 kg.
- Severe comorbidity contraindicating therapeutic options or invasive thoracic diagnostic investigations.
- Inability to climb two flights of stairs without stopping.
- A thoracic CTscan performed within the previous year.
- Persons deprived of liberty or under guardianship.
- Impossibility to undergo the medical monitoring of the trial for geographical, social or psychological reasons.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Centre CTPS Bobigny Bondy
Bobigny, 93000
Hortense FONKOUA, MD
- Not yet recruiting
Centre Municipal de Santé de Gentilly
Gentilly, 94250
Bourrely Florence, MD
- Recruiting
Centre Municipal de Santé Simone Veil
Issy-les-Moulineaux, 92160
Coline CORTICCHIATO, MD
- Not yet recruiting
Centre Municipal de Santé Jacqueline Akoun-Cornet
Malakoff, 92240
Amandine HUYGHE, MD
- Recruiting
Centre Municipal de Santé Maurice Ténine
Malakoff, 92240
Eric MAY, MD
- Recruiting
Centre de Santé Square de la Mutualité
Paris, 75005
Angélique SENTILHES, MD
- Not yet recruiting
Institut Curie
Paris, 75248
Catherine DANIEL, MD
- Not yet recruiting
Institut Mutualiste Montsouris
Paris, 75674
Thibault VIEIRA, MD
- Recruiting
Centre de Santé MGEN
Paris, 75738
David BLONDEEL, MD
About this study
Official title: Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)
The aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study.
Read the detailed description
The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualists and its affiliated health centers, is based on a clear, simple and functional process:
- Definition of eligibility criteria for screening, based on those of the NELSON study,
- Referral and consultation by a health center physician trained in these criteria,
- Referral and performance of a chest Computer Tomography Scanner (CTscan) according to the same recommendations,
- Structured centralized reading and interpretation of CTscan images,
- Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected,
- Referral to a tobacco unit in a health center for smokers who have not stopped smoking,
- Organization of follow-up and continuation of the screening program.
- Conditions
- Bronchopulmonary Disease, Diagnoses Disease
- Being tested
- Screening, Inclusion, Chest CTscan and follow-up
- Keywords
- bronchopulmonary cancer, screening, primary prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
A first step to identify and recruit people eligible for screening,
InclusionOther
A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center,
Chest CTscan and follow-upOther
A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| Screening for primary prevention of bronchopulmonary cancer | Other | Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years), Receives: Other: Screening; Other: Inclusion; Other: Chest CTscan and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of first CTscan for bronchopulmonary cancer screening
Rate of completion of a first bronchopulmonary cancer screening among people who have joined the program (i.e. registered on the program's web platform and met the inclusion criteria).
Measured: 36 months
Secondary outcomes (10)
Eligibility rate among people registering on the web platform
Ratio of the number of eligible people (meeting all inclusion and inclusion criteria and no non-inclusion criteria) to the total number of people registered on the web platform.
Measured: 36 months
Rate of completion of the inclusion visit among people registered on the web platform,
Ratio of the number of people who have completed the inclusion visit to the total number of eligible people registered on the web platform
Measured: 36 months
Rate of completion of screening scanners at 1 year according to NELSON trial schedule
Ratio of the number of people who had their 1-year screening CTscan among those eligible for a 1-year CTscan
Measured: 48 months
Rate of completion of screening scanners at 3 years according to NELSON trial schedule
Ratio of the number of people who had their 3-year screening CTscan among those eligible for a 3-year CTscan
Measured: 72 months
Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule
Ratio of the number of people who had their 5.5-year screening CTscan among those eligible for a 5.5-year CTscan
Measured: 102 months
Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan
Demographic characteristics at inclusion will be compared between people who have or have not had at least one nodule detected on one of the 4 CTscan.
Measured: 102 months
Rate of complications related to complementary explorations
Ratio between the number of people with complications related to complementary explorations and the population having undergone a CT scan.
Measured: 102 months
Smoking cessation rates during the screening program
The rate of newly non-smoking subjects will be calculated for each type of approach by dividing the number of newly non-smoking subjects by the number of subjects people included in the study.
Measured: 102 months
Rate of early-stage bronchopulmonary cancers identified
Number of bronchopulmonary cancers detected at an early stage (stage I or stage II) to the total number of people who underwent a CTscan at inclusion
Measured: 102 months
Rate of positive screening without bronchopulmonary cancer
The rate of false-positive screening will be calculated by people who have at least one positive screening scanner, but whose histology has not confirmed their malignancy, to the number people who had a scanner
Measured: 102 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start27 Jan 2025
- Primary completion5 Feb 2033 (estimated)
- Study completion5 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DiseaseStudies 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
- Multicentre, Interregional , feasibility study
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Mutualiste Montsouris
- Responsible party
- Sponsor
- Investigators
- Catherine DANIEL, MD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439901
- Sponsor's protocol ID
- IC 2023-11
- Acronym
- OPTI-DEPIST
- Status last verified
- Sep 2026
- First submitted
- 28 May 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)
- ClinicalTrials.gov ID
- NCT06439901
- Acronym / sponsor ID
- OPTI-DEPIST / IC 2023-11
- Conditions
- Bronchopulmonary Disease, Diagnoses Disease
- Keywords
- bronchopulmonary cancer, screening, primary prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Institut Mutualiste Montsouris
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 5 Feb 2033 (estimated)
- Study completion
- 5 Feb 2034 (estimated)
- First posted
- 3 Jun 2024 (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 aim of this study is to evaluate the feasibility of performing a first screening for bronchopulmonary cancer by thoracic scanner in a French cohort within a dedicated, effective and structured network in the pilot centers participating in the study.
Detailed description
The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualists and its affiliated health centers, is based on a clear, simple and functional process:
- Definition of eligibility criteria for screening, based on those of the NELSON study,
- Referral and consultation by a health center physician trained in these criteria,
- Referral and performance of a chest Computer Tomography Scanner (CTscan) according to the same recommendations,
- Structured centralized reading and interpretation of CTscan images,
- Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected,
- Referral to a tobacco unit in a health center for smokers who have not stopped smoking,
- Organization of follow-up and continuation of the screening program.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentre, Interregional , feasibility study
| Arm | Type | Receives |
|---|---|---|
| Screening for primary prevention of bronchopulmonary cancer | Other | Other: Screening, Other: Inclusion, Other: Chest CTscan and follow-upScreening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years), |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant aged 50 to 74.
- Resident in the Île-de-France region.
- Active smoker or quit smoker for 10 years or less:
- The participant has been informed and has signed the consent form.
- Social Security System affiliation.
Key exclusion criteria (8 listed)
- Active cancer or a history of cancer in remission for less than 5 years (except basal cell carcinoma of th skin or epithelioma in situ of the uterine cervix).
- Presence of symptoms suggestive of bronchopulmonary cancer. Participants with these symptoms require immediate diagnostic investigations and are therefore not eligible for screening.
- Weight >= 140 kg.
- Severe comorbidity contraindicating therapeutic options or invasive thoracic diagnostic investigations.
- Inability to climb two flights of stairs without stopping.
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 |
|---|---|---|
| ScreeningA first step to identify and recruit people eligible for screening, | Other | Screening for primary prevention of bronchopulmonary cancer |
| InclusionA second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center, | Other | Screening for primary prevention of bronchopulmonary cancer |
| Chest CTscan and follow-upA third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care. | Other | Screening for primary prevention of bronchopulmonary cancer |
Primary outcome
Rate of first CTscan for bronchopulmonary cancer screening
Time frame: 36 months
Rate of completion of a first bronchopulmonary cancer screening among people who have joined the program (i.e. registered on the program's web platform and met the inclusion criteria).
10 secondary outcomes
Eligibility rate among people registering on the web platform
Time frame: 36 months
Rate of completion of the inclusion visit among people registered on the web platform,
Time frame: 36 months
Rate of completion of screening scanners at 1 year according to NELSON trial schedule
Time frame: 48 months
Rate of completion of screening scanners at 3 years according to NELSON trial schedule
Time frame: 72 months
Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule
Time frame: 102 months
Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan
Time frame: 102 months
Rate of complications related to complementary explorations
Time frame: 102 months
Smoking cessation rates during the screening program
Time frame: 102 months
Rate of early-stage bronchopulmonary cancers identified
Time frame: 102 months
Rate of positive screening without bronchopulmonary cancer
Time frame: 102 months
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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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.
Catherine DANIEL, MD study director
Institut Curie
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening, Inclusion and Chest CTscan and follow-up in people with Bronchopulmonary Disease and Diagnoses Disease, run by Institut Curie at 9 sites 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Contact Catherine DANIEL, MD (+33 1 44 32 40 00, catherine.daniel@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of first CTscan for bronchopulmonary cancer screening (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.