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Идёт набор NCT07517393

Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)

— Наблюдательное Thoracic Neoplasm Pulmonary Nodules Non-oncological Pulmonary Pathologies

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Thoracic Neoplasm, Pulmonary Nodules, Non-oncological Pulmonary Pathologies. 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
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Официальное название

LUCE: LUng Cancer (r)Evolution

Обзор

This research study aims to retrospectively and prospectively analyze the clinical, anamnestic, functional, biological data of patients who have performed or will perform non-contrast chest photon count CT. The use of contrast medium is evaluated by the physician. Main objective The study aims to understand how many people who undergo non-contrast photon-counting chest CT have: lung nodules, chest tumors, and other non-cancerous lung diseases. Secondary objectives * Analyze the data with the help of artificial intelligence to create a "digital twin" of the lung, that is, a virtual copy of the lung that allows you to study and simulate the behavior of the lung for research and analysis purposes, without directly intervening on the patient. * Follow any suspicious lung changes over time to understand how they change and whether they are linked to clinical, biological, or laboratory parameters. The enrollment phase will last 12 months and will begin with the approval of the study. At this stage, clinical data already present in the patient's medical record and data relating to the photon count CT examination will be collected. After the enrollment phase, the patient will be observed for a further total duration of 10 years: in particular, a follow-up visit will be arranged at two, five and ten years. More specifically, if there are no radiological elements that require scheduling a visit to the center, the patient will be contacted by telephone for a telematic update of the data. If, however, pulmonary alterations are identified during the study, the patient will be referred to the Reference Operating Unit, as per clinical practice, to continue with the most appropriate personalized diagnostic-therapeutic process. In these cases, the patient will be contacted by telephone and an appointment with the institution will be suggested.

Первичные конечные точки

  • Describe the frequency of patients performing chest photon counting CT without mdc with pulmonary nodules [Срок оценки: through study completion, an average of 1 year]
  • Describe the frequency of thoracic malignancies in subjects performing chest photon counting CT without mdc. [Срок оценки: through study completion, an average of 1 year]
  • Describe the frequency of non-oncological pulmonary diseases of subjects performing chest photon counting CT without mdc. [Срок оценки: through study completion, an average of 1 year]
Вторичные конечные точки (3)
  • Accuracy of the AI-based lung digital twin model measured by mean absolute error (MAE) between model-predicted and observed pulmonary function parameters (FEV1, FVC, DLCO) [Срок оценки: through study completion, an average of 1 year]
  • Change in lung structural abnormalities measured by quantitative CT parameters (lung density, lung volume, lesion size) [Срок оценки: through study completion, an average of 1 year]
  • Association between lung imaging abnormalities and clinical, biological, and laboratory variables assessed by multivariable regression analysis [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

  • Men or women aged ≥ 18 years who will perform a smdc photon count chest CT scan
  • written informed consent.

Критерии исключения

  • Lack of information regarding anamnestic data
  • any reason why the investigator deems the patient unenrollable in the practice.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Италия · 1 центр
  • Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda

Идентификаторы

NCT: NCT07517393 · 887CET

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗