Optimizing Bronchopulmonary Cancer Screening

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Rate of first CTscan for bronchopulmonary cancer screening [Срок оценки: 36 months]

Вторичные конечные точки (10)

• Eligibility rate among people registering on the web platform [Срок оценки: 36 months]
• Rate of completion of the inclusion visit among people registered on the web platform, [Срок оценки: 36 months]
• Rate of completion of screening scanners at 1 year according to NELSON trial schedule [Срок оценки: 48 months]
• Rate of completion of screening scanners at 3 years according to NELSON trial schedule [Срок оценки: 72 months]
• Rate of completion of screening scanners at 5.5 years according to NELSON trial schedule [Срок оценки: 102 months]
• Correlation of demographic characteristics and the detection of a nodule during the 4 CTscan [Срок оценки: 102 months]
• Rate of complications related to complementary explorations [Срок оценки: 102 months]
• Smoking cessation rates during the screening program [Срок оценки: 102 months]
• Rate of early-stage bronchopulmonary cancers identified [Срок оценки: 102 months]
• Rate of positive screening without bronchopulmonary cancer [Срок оценки: 102 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 8 центров

• Centre CTPS Bobigny Bondy — Bobigny
• Centre Municipal de Santé Simone Veil — Issy-les-Moulineaux
• Centre Municipal de Santé Jacqueline Akoun-Cornet — Malakoff
• Centre Municipal de Santé Maurice Ténine — Malakoff
• Centre de Santé Square de la Mutualité — Paris
• Institut Curie — Paris
• Institut Mutualiste Montsouris — Paris
• Centre de Santé MGEN — Paris

Идентификаторы

NCT: NCT06439901 · IC 2023-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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