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Идёт набор NCT06295497

Lung Cancer Screening in HIgh Risk nonsmokErs by Artificial inteLligence Device

Без фазы С лечением Lung Cancer

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: Lung-SIGHT.
Кому может быть актуально
Состояния в реестре: Lung Cancer. Базовые параметры: 50 лет — 75 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
Гонконг
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

A Prospective Study on Artificial Intelligence Guided Lung Cancer Screening for High-risk Never Smokers in Hong Kong

Обзор

Lung cancer screening is currently not recommended in non-smokers due to paucity of evidence. Emerging evidence suggests that first-degree family history is a strong risk factor for lung cancer in Asian non-smokers. In Asia, lack of resource is a major challenge in successful implementation of lung cancer screening. Artificial intelligence (AI) is a promising tool to overcome this resource. In this study, we aim to study the clinical utility and demonstrate the feasibility of using an AI assisted programme for lung cancer screening in Asian non-smokers with a positive family history. This is a single-arm non-randomized lung cancer screening study. 3000 non-smokers, age 50 to 75 year old, with a first-degree family history of lung cancer, will be enrolled. Participants will undergo low does computed tomography (LDCT) of thorax and blood taking at enrolment. LDCT films will be interpreted by AI softwares for presence of lung nodules. Participants with lung nodules will be further investigated and followed up according to the risk of malignancy. The primary endpoint is the prevalence of early-staged lung cancer detected by first-round LDCT thorax in this population.

Вмешательства

  • Устройство Lung-SIGHT
    * The LDCT images will be interpreted by an artificial intelligence-based programme (Lung-SIGHT) for lung nodules. * b. In phase I, AI will serve as a first reader to screen LDCT scans. LDCT with lung nodules \>=5mm will be marked as abnormal, sent for reporting by board-certified radiologists and followed up in lung nodule clinic if the presence of lung nodules is confirmed. * c. In phase II, LDCT with lung nodules \>=5mm detected by AI will be categorized into different groups depending on ris

Первичные конечные точки

  • Sensitivity, specificity, positive predictive value and negative predictive value of AI-assisted programme in lung nodule (≥5mm) detection and monitoring compared to radiologist assessment [Срок оценки: 2 years]
Вторичные конечные точки (6)
  • Sensitivity, specificity, positive predictive value and negative predictive value of AI-assisted programme in lung cancer detection [Срок оценки: 2 years]
  • Diagnostic utility of plasma-based biomarker for detection and risk assessment of early-staged lung cancer [Срок оценки: 2 years]
  • Rate of invasive workup and associated complications [Срок оценки: 2 years]
  • Stage distribution of lung cancer detected by LDCT screening [Срок оценки: 2 years]
  • Prevalence of lung cancer detected by second-round LDCT (T1) in patients with negative first-round LDCT [Срок оценки: 2 years]
  • Cost effectiveness of LDCT lung cancer screening using AI-assisted programme [Срок оценки: 2 years]

Критерии участия

Критерии включения

Patients are eligible to be included in the study only if all of the following criteria apply:

  • Age 50-75 years old
  • Non-smoker (defined as less than 100 cigarettes in lifetime)
  • Having a first-degree family history of lung cancer
  • Physically fit for curative treatment if early-staged lung cancer is found
  • Able to provide written informed consent
  • Consent to follow up visits and follow up CT scan if indicated
  • Consent to blood taking for translational research

Критерии исключения

Patients who meet any of the following exclusion criteria at screening are not eligible to be enrolled in this study:

  • History of malignancy
  • Smoking history (defined as more than 100 cigarettes in lifetime)
  • Clinical symptoms suspicious for lung cancer e.g. haemoptysis, chest pain, weight loss
  • Medical comorbidities that preclude curative treatment (surgery) for lung cancer, such as severe heart disease, acute or chronic respiratory failure, home oxygen therapy, bleeding disorder
  • Pregnant ladies or ladies planning for conception
  • History of tuberculosis or interstitial lung disease
  • Pneumonia requiring antibiotic treatment within the last 12 weeks
  • CT thorax or chest performed within 2 years (including LDCT, PET-CT, MRI thorax or suspicious of lung cancer)
  • Unable or unwilling to provide written informed consent

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
Скрининг

Центры проведения

Гонконг · 1 центр
  • Department of Clinical Oncology, Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT06295497 · LC-SHIELD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗