Optimizing Bronchopulmonary Cancer Screening (OPTI-DEPIST)

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.

Study Overview

• Status: Recruiting
• Conditions: Diagnoses Disease; Bronchopulmonary Disease
• Intervention / Treatment: Other: Screening; Other: Inclusion; Other: Chest CTscan and follow-up

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 Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine DANIEL, MD; Phone Number: +33 1 44 32 40 00; Email: catherine.daniel@curie.fr
• Study Contact Backup: Name: Nicolas GiRARD, PhD; Phone Number: +33 1 44 32 40 00; Email: nicolas.girard@curie.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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.

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: 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; A first step to identify and recruit people eligible for screening,; Other: Inclusion; A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center,; Other: Chest CTscan and follow-up; A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	36 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.	102 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	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	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	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.	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.	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	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	102 months

Collaborators and Investigators

• Sponsor: Institut Curie
• Collaborators: Institut Mutualiste Montsouris
• Investigators: Study Director: Catherine DANIEL, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): February 5, 2033
• Study Completion (Estimated): February 5, 2034

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 28, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: screening; primary prevention; bronchopulmonary cancer
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Mass Screening
• Other Study ID Numbers: IC 2023-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No