- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT04675138
Development of a Clinical Decision Support System With Artificial Intelligence for Cancer Care
Clinical Decision Support Systems (CDSSs) to augment clinical care and decision making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information.
In view of the benefit of developing a CDSS, we sought to develop an alternative CDSS for oncologic therapy selection through a partnership with Ping An Technology (Shenzhen, China), beginning with gastric and oesophagal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated by comparing its recommendations with that from the multidisciplinary tumour boards of several tertiary care institutions to determine the concordance rate.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Management of cancer is a complex process which involves numerous stakeholders. In view of this, institutions worldwide have adopted the use of Multidisciplinary Tumor Boards (MTBs) for delivery of cancer care. By tapping on the collective specialized knowledge and experience of various specialties, MTBs have been shown in some studies to result in more appropriate recommendations and improved patient outcomes. At our institution, cancer cases are similarly discussed at regular MTBs which comprises surgeons, oncologists, pathologists and radiologists who review and recommend treatments.
However, in smaller centres or centres with limited resources and minimal multi-disciplinary expertise, delivery of timely and appropriate cancer care could be a challenge. Additionally, clinicians, with their busy schedule, may not be able to keep abreast of new developments in cancer research. With rapid advances in scientific research, this pool of knowledge is expected to continue to burgeon, making keeping up-to-date increasingly onerous.
To address this need, clinicians have adopted the use of Clinical Decision Support Systems (CDSSs) to augment clinical care and decision-making. These are platforms which aim to improve healthcare delivery by enhancing medical decisions with targeted clinical knowledge, patient information, and other health information. Various studies have shown CDSSs to be beneficial in selected settings such as patient safety and diagnosis [4], and to even increase adherence to clinical guidelines. In recent years, advancements in artificial intelligence have also seen its use expand to include oncologic therapy selection, with IBM's Watson for Oncology (WFO) being the most prominent and only platform in use to-date. In a 2018 study, WFO's ability to provide treatment advice for breast cancer was compared against recommendations from a multidisciplinary board, where it showed a high degree of concordance. Since then, several other studies have sought to examine WFO's ability to provide treatment recommendations for cancer such as ovarian, gastric, lung, cervical and colorectal cancers, with mixed results. In particular, both studies which examined the recommendations for gastric cancers showed a much lower concordance rate compared to other cancers.
In view of the above, we sought to develop an alternative CDSS for oncologic therapy selection through partnership with Ping An Technology (Shenzhen, China), beginning with gastric and esophageal cancer. This would be done in a piecemeal fashion, with the prototype platform utilizing only international guidelines and high-quality published evidence from journals to arrive at case-specific treatment recommendations. This platform would then be evaluated retrospectively and prospectively by comparing its recommendations with that from the multidisciplinary tumor boards of several tertiary care institutions to determine the concordance rate.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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Singapore, Сингапур, 119228
- Рекрутинг
- National University Hospital
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Контакт:
- Jimmy So, MBChB
- Номер телефона: 24236 +65 6772 5555
- Электронная почта: sursbyj@nus.edu.sg
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Контакт:
- Guowei Kim, MBBS
- Номер телефона: 28830 +65 6772 5555
- Электронная почта: guo_wei_kim@nuhs.edu.sg
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
A. In discovery and internal retrospective validation part:
- Patients with primary gastric adenocarcinoma including preinvasive carcinoma or
- Patients with gastroesophageal junction cancers or
- Patients with oesophageal cancer including adenocarcinoma, squamous cell carcinoma and preinvasive carcinoma subtypes.
B. In prospective validation part:
- Patients with primary gastric adenocarcinoma including preinvasive carcinoma or
- Patients with esophageal or gastroesophageal junction adenocarcinoma
Exclusion Criteria:
A. In discovery and internal retrospective validation part:
- Patients with other primary cancers involving the stomach or oesophagus
- Patients with other cancer subtypes
- Patients with concomitant cancers of other organs
B. In prospective validation part:
- Patients with esophageal squamous cell carcinoma
- Patients who participate in clinical trials where the treatment modality is not standard of care
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Concordance Rate
Временное ограничение: 1 to 2 years
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Comparative agreement in recommendations between the two study groups, as measured by concordance rate
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1 to 2 years
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Reason for Discordance
Временное ограничение: 1 to 2 years
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To identify the reason for the discordance
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1 to 2 years
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Соавторы и исследователи
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- Новообразования
- Новообразования по локализации
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания желудка
- Новообразования головы и шеи
- Заболевания пищевода
- Новообразования желудка
- Новообразования пищевода
Другие идентификационные номера исследования
- 2020/00493
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .