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NCT Number: NCT06439901

Optimizing Bronchopulmonary Cancer Screening

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.

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Key information

Conditions

Bronchopulmonary Disease Diagnoses Disease

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre CTPS Bobigny Bondy, Bobigny, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Screening

Other

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

Inclusion

Other

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-up

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Eligibility rate among people registering on the web platform

    Time frame: 36 months

    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.

  2. Rate of completion of the inclusion visit among people registered on the web platform,

    Time frame: 36 months

    Ratio of the number of people who have completed the inclusion visit to the total number of eligible people registered on the web platform

  3. Rate of completion of screening scanners at 1 year according to NELSON trial schedule

    Time frame: 48 months

    Ratio of the number of people who had their 1-year screening CTscan among those eligible for a 1-year CTscan

  4. Rate of completion of screening scanners at 3 years according to NELSON trial schedule

    Time frame: 72 months

    Ratio of the number of people who had their 3-year screening CTscan among those eligible for a 3-year CTscan

  5. Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule

    Time frame: 102 months

    Ratio of the number of people who had their 5.5-year screening CTscan among those eligible for a 5.5-year CTscan

  6. Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan

    Time frame: 102 months

    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.

  7. Rate of complications related to complementary explorations

    Time frame: 102 months

    Ratio between the number of people with complications related to complementary explorations and the population having undergone a CT scan.

  8. Smoking cessation rates during the screening program

    Time frame: 102 months

    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.

  9. Rate of early-stage bronchopulmonary cancers identified

    Time frame: 102 months

    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

  10. Rate of positive screening without bronchopulmonary cancer

    Time frame: 102 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine DANIEL, MD

CONTACT

[email protected]

+33 1 44 32 40 00

Nicolas GiRARD, PhD

CONTACT

[email protected]

+33 1 44 32 40 00

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Collaborators

  • Institut Mutualiste Montsouris

Registry information

Official study title

Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)

Acronym: OPTI-DEPIST

Important dates

Study start
2025
Primary completion
2033
Study completion
2034
First posted
Jun 3, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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