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Идёт набор NCT06002425

Treatment Recommendations for Gastrointestinal Cancers Via Large Language Models

Без фазы С лечением Gastrointestinal Neoplasm Malignant

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: Clinician-Directed Treatment Plan, ChatGPT-Assisted Treatment Plan.
Кому может быть актуально
Состояния в реестре: Gastrointestinal Neoplasm Malignant. 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
США, Китай, Германия, Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Application of Large Language Models in the Recommendation of Treatment Plans for Gastrointestinal Cancers

Обзор

This study will evaluate the utility of ChatGPT in recommending treatment plans for patients with gastrointestinal cancers, using both retrospective and prospective data.

Подробное описание

The medical records of over 1,200 patients with gastrointestinal cancers will be collected retrospectively from participating hospitals. This data will be split into an exploratory dataset (n=200) and a validation dataset (n\>=1,000). Within the exploratory dataset, various prompt methods will be used to determine the treatment plans suggested by ChatGPT. Additionally, several clinicians of varied seniority levels will provide their treatment recommendations. For the validation dataset, ChatGPT's suggestions for treatment plans will undergo both qualitative and quantitative assessments by a multidisciplinary consultation (MDT) team. The recommendations from ChatGPT will then be compared with those from the clinicians.

Furthermore, this study will incorporate a prospective dataset comprising 400 participants with gastrointestinal cancers. The participants will be randomly allocated to either a control group (n=200) or a ChatGPT-Assisted group (n=200). In the control group, treatment plan recommendations will solely be provided by the clinicians and will guide subsequent treatments. In the ChatGPT-Assisted group, initial treatment plan recommendations will be independently proposed by both ChatGPT and the clinicians. Based on ChatGPT's suggestions, clinicians might selectively adjust their initial plans. Participants will then receive treatments as per these refined plans. Within the ChatGPT-Assisted group, the treatment plans of the initial 100 participants will be evaluated to determine the percentage of patients whose treatment plans are influenced by ChatGPT. Subsequently, the proportion of participants in the entire ChatGPT-Assisted group with treatment plans modified by ChatGPT will be calculated. The study will further monitor the 3-year progression-free survival (PFS) and the 5-year overall survival (OS) rates, contrasting the outcomes between the control and ChatGPT-assisted groups.

Вмешательства

  • Другое Clinician-Directed Treatment Plan
    In this approach, clinicians do not employ any technological assistance and rely solely on their professional expertise and experience to formulate treatment plans for participants.
  • Другое ChatGPT-Assisted Treatment Plan
    In this approach, clinicians utilize the ChatGPT technological tool, formulating treatment plans for participants based on its suggestions and their own professional expertise.

Первичные конечные точки

  • Influence Rate of ChatGPT on Treatment Plans [Срок оценки: Within 24 hours after the treatment plan is determined from the onset of study participation.]
Вторичные конечные точки (1)
  • 3-year Progression-Free Survival (PFS) Rate [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Age ≥18 years, both male and female.
  • Pathologically confirmed diagnosis of gastrointestinal cancer (gastric cancer or colorectal Cancer).
  • Detailed medical records available prior to treatment (including chief complaint, history of present illness, radiological examinations, pathological examinations, laboratory tests, etc.).
  • Participants will receive complete treatment in the participating hospitals.

Критерии исключения

  • Participants with cancers other than gastrointestinal cancers.
  • Participants who receive treatment in multiple hospitals.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 4 центра
  • Jiangmen Central Hospital — Jiangmen
  • The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
  • Zhuhai People's Hospital — Zhuhai
  • Peking University Cancer Hospital (Inner Mongolia Campus) — Hohhot
США · 1 центр
  • City of Hope — Duarte
Германия · 1 центр
  • University Hospital Magdeburg — Magdeburg
Италия · 1 центр
  • San Raffaele University Hospital, Italy — Milan

Идентификаторы

NCT: NCT06002425 · CASMI006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗