Optimizing Bronchopulmonary Cancer Screening
OPTI-DEPIST
Optimizing the Implementation of Bronchopulmonary Cancer Screening in the Ile de France Region (OPTI-DEPIST-MUT)
1 other identifier
interventional
500
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 3, 2024
CompletedStudy Start
First participant enrolled
January 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 17, 2033
February 3, 2025
January 1, 2025
7 years
May 28, 2024
January 30, 2025
Conditions
Keywords
Outcome Measures
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).
36 months
Secondary Outcomes (10)
Eligibility rate among people registering on the web platform
36 months
Rate of completion of the inclusion visit among people registered on the web platform,
36 months
Rate of completion of screening scanners at 1 year according to NELSON trial schedule
48 months
Rate of completion of screening scanners at 3 years according to NELSON trial schedule
72 months
Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule
102 months
- +5 more secondary outcomes
Study Arms (1)
Screening for primary prevention of bronchopulmonary cancer
OTHERScreening CTscan according to the NELSON trial schedule (at inclusion, 1 year, 3 years, 5.5 years),
Interventions
A first step to identify and recruit people eligible for screening,
A second step for inclusion of participants, with an online self-questionnaire and information, and an inclusion visit to the health center,
A third step with an initial CTscan, with dual interpretation and appropriate management of participants, including follow-up care.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Curielead
- Institut Mutualiste Montsouriscollaborator
Study Sites (8)
Centre CTPS Bobigny Bondy
Bobigny, 93000, France
Centre Municipal de Santé Simone Veil
Issy-les-Moulineaux, 92160, France
Centre Municipal de Santé Jacqueline Akoun-Cornet
Malakoff, 92240, France
Centre Municipal de Santé Maurice Ténine
Malakoff, 92240, France
Centre de Santé Square de la Mutualité
Paris, 75005, France
Institut Curie
Paris, 75248, France
Institut Mutualiste Montsouris
Paris, 75674, France
Centre de Santé MGEN
Paris, 75738, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Catherine DANIEL, MD
Institut Curie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 3, 2024
Study Start
January 17, 2025
Primary Completion (Estimated)
January 17, 2032
Study Completion (Estimated)
January 17, 2033
Last Updated
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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).
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.