Optimizing Bronchopulmonary Cancer Screening

Diagnoses Disease Clinical Trial

— OPTI-DEPIST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439901
• Other study ID #: IC 2023-11
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: June 30, 2032

Study information

• Verified date: April 2024
• Source: Institut Curie
• Contact: Catherine DANIEL, MD
• Phone: +33 1 44 32 40 00
• Email: catherine.daniel[@]curie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 strutured network in the pilot centers participating in the study.

Description:

The organization of bronchopulmonary cancer screening in the Ile de France region, within the Mutualité 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 CT scan according to the same recommendations,

• Structured centralized reading and interpretation of CT scan images,

• Referral to a multidisciplinary team (CITT), if bronchopulmonary cancer is suspected,

• Referral to a tobaccology unit in a health center for smokers who have not stopped smoking,

• Organization of follow-up and continuation of the screening program.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: June 30, 2032
• Est. primary completion date: June 30, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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 CT scan 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.

Related Conditions & MeSH terms

• Bronchopulmonary Disease
• Diagnoses Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Institut Curie	Institut Mutualiste Montsouris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of first CT scan 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	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
Secondary	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
Secondary	Rate of completion of screening scans at 1 year according to NELSON trial schedule	Ratio of the number of people who had their 1-year screening scan CT among those eligible for a 1-year scan	48 months
Secondary	Rate of completion of screening scans at 3 years according to NELSON trial schedule	Ratio of the number of people who had their 3-year screening scan CT among those eligible for a 3-year scan	72 months
Secondary	Rate of completion of screening scans at 5.5 years according to NELSON trial schedule	Ratio of the number of people who had their 5.5-year screening scan CT among those eligible for a 5.5-year scan	102 months
Secondary	Correlation of demographic characteristics and the detection of a nodule during the 4 scans	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 scans.	102 months
Secondary	Complications related to complementary explorations of positive screenings	The pourcentage will be estimated by dividing the observed population by the population at risk	102 months
Secondary	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
Secondary	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 CT scan at inclusion	102 months
Secondary	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 scan, but whose histology has not confirmed their malignancy, to the number people who had a scan	102 months