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Идёт набор NCT06626178

Development of an Artificial Intelligence Model for the Identification and Prevention of Smoking-related Diseases.

Без фазы С лечением Lung Cancer Screening Program Artificial Intelligence (AI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Computed tomography (CT) scan low dose, Blood sampling, Tissue sampling (lung), Spirometry.
Кому может быть актуально
Состояния в реестре: Lung Cancer Screening Program, Artificial Intelligence (AI). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

ARtificial Intelligence for heAlth and Prevention of Smoking-related Diseases

Обзор

The study is an interventional pilot study. The study is designed to be monocentric and it presents additional procedues.

Подробное описание

Interventional pilot study, single-center with additional procedures, such as completion of EORTC-QLQ-LC29, EORTC-QLQ-C30 questionnaires, motivational test, Fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, Low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml.

The study has the main objective of traininig and validate a reliable and unbiased Artificial Intelligence (AI) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types.

The study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this Institute.

Вмешательства

  • Диагностический тест Computed tomography (CT) scan low dose
    The radiological investigation will be done with multi-detector-row (64 or more) computed tomography (CT) scanners at low-dose protocol. The low-dose spiral CT consists of a CT study of the chest, without the need for injection of contrast medium, characterized by less radio exposure than the standard CT of the chest with high sensitivity in detecting pulmonary nodules.
  • Процедура Blood sampling
    Peripheral venous blood sampling (20 ml)
  • Процедура Tissue sampling (lung)
    sampling of tumor and healthy tissue during surgery
  • Другое Spirometry
    Spirometry measurement using spirometer
  • Другое Questionnaires
    Compilation of epidemiological questionnaire, quality of life questionnaires
  • Другое Smoking cessation program
    Study guarantee valid support for quitting smoking, which for a smoker is a more effective intervention to reduce the risk of developing lung cancer, myocardial infarction and other smoking-related diseases
  • Другое Carbon monoxide measurment
    Measurment of Carbon monoxide (CO)
  • Другое Cardiovascular primary prevention
    Intervention done in order to find the presence of coronary calcifications

Первичные конечные точки

  • Creation of Artificial Intelligence (AI) algorithm [Срок оценки: from enrollment to 48 months]
Вторичные конечные точки (1)
  • Multimodal program [Срок оценки: from enrollment to 48 months]

Критерии участия

High-risk screening subjects

Критерии включения

  • Age >= 50 years old
  • Active smokers
  • Former smokers (from no more than 15 years)
  • Pack/year >20
  • Risk-prediction model from Prostate, Lung, Colorectal, and Ovarian study (PLCOm2012) >1.2%
  • Provision and signature of informed consent

Критерии исключения

  • Previous or concurrent neoplastic disease, excluding skin cancers
  • Cognitive or other problems that could hinder the collection of informed consent
  • Severe pulmonary or extra pulmonary disease
  • Previous low-dose computed tomography (CT) scan in the past 12 months

Previous high-risk positive screening subjects

Критерии включения

  • Subjects enrolled in previous lung cancer screening with the presence of lung nodules >4 mm and candidate to additional computed tomography (CT)
  • Signed informed consent

Критерии исключения

\- None

Previous high-risk negative screening subjects

Критерии включения

  • Subjects enrolled in previous lung cancer screening in this Institute with negative computed tomography (CT)
  • Signed informed consent

Критерии исключения

\- None

Lung Cancer patients

Критерии включения

  • Patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it
  • Patients with diagnosis of lung cancer treated with surgical resection
  • Signed informed consent

Критерии исключения

  • computed tomography (CT) scans not available at San Raffaele Hospital
  • Previous neoadjuvant treatment

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Италия · 1 центр
  • Scientific Institute Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT06626178 · CET 288-2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗