ClinicalTrials.gg
RecruitingNCT06439901OPTI-DEPISTUpdated Sep 10, 2026

Optimizing Bronchopulmonary Cancer Screening

An interventional study of Screening and Inclusion in Bronchopulmonary Disease and Diagnoses Disease, sponsored by Institut Curie. Recruiting at 9 sites in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Institut Curie · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
50 Years to 74 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Bronchopulmonary Disease
  • Diagnoses Disease

Keywords

  • bronchopulmonary cancer
  • screening
  • primary prevention
03

In context

Lead sponsor

Institut Curie is the lead sponsor of 135 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant aged 50 to 74.
  • Resident in the Île-de-France region.
  • Active smoker or quit smoker for 10 years or less:

    1. more than 10 cigarettes a day for more than 30 years,
    2. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Other
    Screening for primary prevention of bronchopulmonary cancer

    Screening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years),

    Other: Screening · Other: Inclusion · Other: Chest CTscan and follow-up

Interventions

  • OtherScreening

    A first step to identify and recruit people eligible for screening,

  • OtherInclusion

    A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center,

  • OtherChest CTscan and follow-up

    A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 36 months

Secondary outcomes

  1. 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.

    Time frame: 36 months

  2. 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

    Time frame: 36 months

  3. 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

    Time frame: 48 months

  4. 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

    Time frame: 72 months

  5. 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

    Time frame: 102 months

  6. 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.

    Time frame: 102 months

  7. 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.

    Time frame: 102 months

  8. 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.

    Time frame: 102 months

  9. 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

    Time frame: 102 months

  10. 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

    Time frame: 102 months

07

Study locations

4 of 9 sites recruiting
  • Centre CTPS Bobigny Bondy
    Bobigny, 93000, France
    Not yet recruiting
    • Hortense FONKOUA, MD · Contact
  • Centre Municipal de Santé de Gentilly
    Gentilly, 94250, France
    Not yet recruiting
    • Bourrely Florence, MD · Contact
  • Centre Municipal de Santé Simone Veil
    Issy-les-Moulineaux, 92160, France
    Recruiting
    • Coline CORTICCHIATO, MD · Contact
  • Centre Municipal de Santé Jacqueline Akoun-Cornet
    Malakoff, 92240, France
    Not yet recruiting
    • Amandine HUYGHE, MD · Contact
  • Centre Municipal de Santé Maurice Ténine
    Malakoff, 92240, France
    Recruiting
    • Eric MAY, MD · Contact
  • Centre de Santé Square de la Mutualité
    Paris, 75005, France
    Recruiting
    • Angélique SENTILHES, MD · Contact
  • Institut Curie
    Paris, 75248, France
    Not yet recruiting
    • Catherine DANIEL, MD · Contact
  • Institut Mutualiste Montsouris
    Paris, 75674, France
    Not yet recruiting
    • Thibault VIEIRA, MD · Contact
  • Centre de Santé MGEN
    Paris, 75738, France
    Recruiting
    • David BLONDEEL, MD · Contact
08

References and documents

Individual participant data

Plan to share: Yes — Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.

Access criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2025 (actual). Primary completion is estimated for Feb 2033, 96 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2024
First posted
Jun 3, 2024
StartActual
Jan 27, 2025
Primary completionEst.
Feb 5, 2033
CompletionEst.
Feb 5, 2034
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06439901
Lead sponsor
Institut Curie
Collaborators
Institut Mutualiste Montsouris
Responsible party
Sponsor
First posted
Jun 3, 2024
Start date
Jan 27, 2025
Primary completion
Feb 5, 2033 (estimated)
Completion
Feb 5, 2034 (estimated)
Last update
Sep 10, 2026

Study contacts

Catherine DANIEL, MD
Contact
catherine.daniel@curie.fr
+33 1 44 32 40 00
Nicolas GiRARD, PhD
Contact
nicolas.girard@curie.fr
+33 1 44 32 40 00
Catherine DANIEL, MD
study director · Institut Curie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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