PGHD-AI Intelligent Model for the Nutritional Assessment and Intervention of Patients After Radical Surgery for Pancreatic Cancer.

Официальное название

Evaluation of a Combined PGHD-AI Intelligent Model for the Nutritional Assessment and Intervention of Patients After Radical Surgery for Pancreatic Cancer.

Обзор

This study will collect patient PRO (physical strength, pain, defecation, appetite, weight, etc.) data through the APP, use corpus collection cards, facial photography and other technologies to collect PGHD characteristic phenotypes, and then combine artificial intelligence technology to train and cultivate agents (agents) to carry out joint offline routine follow-up of patients after radical pancreatic cancer resection to evaluate the feasibility of nutritional risk assessment intervention. Thus, the feasibility of artificial intelligence prediction of health status is verified, and an efficient follow-up tool and nutritional support evaluation plan are provided for the management of pancreatic cancer patients throughout the course of the disease, so as to improve the treatment prognosis and quality of life of pancreatic cancer patients.

Подробное описание

This study is a prospective randomized controlled exploratory clinical trial to recruit 200 patients after radical pancreatic cancer resection.

Screening eligible subjects will be randomly assigned to the test group and the control group, and the randomization stratification factors include: age, gender, TNM stage, ECOG score, baseline BMI.

The experimental group and the control group received offline routine follow-up combined with PGHD-AI's APP management and routine outpatient follow-up, respectively, to compare the prediction of nutritional status risk and intervention response.

The study period is 1 year.

Вмешательства

• Другое PGHD's AI intelligent model(APP)
  To collect patient PRO (physical strength, pain, defecation, appetite, weight, etc.) data through the PGHD's AI intelligent model(APP), and use corpus collection cards, facial photography and other technologies to collect PGHD characteristic phenotypes.

Первичные конечные точки

• The incidence and/or improvement rate [Срок оценки: 12 months after enrollment]
• The progression free survival [Срок оценки: 12 months after enrollment]
• The overall survival time [Срок оценки: 12 months after enrollment]

Критерии участия

Критерии включения

• Age: 18-80 years old, and voluntarily signed the informed consent form to participate in the study;
• Meet the clinical and pathological diagnostic criteria for pancreatic cancer (ICD-10:C25);
• After radical surgery, fully recovered from surgery at randomization;
• ECOG PS score 0-1 ;
• Have objective conditions to complete follow-up and examination during the study process.

Критерии исключения

• Patients or their families are willing to use the APP;
• Current history or past history of metastatic or locally recurrent pancreatic cancer;
• Combined with other serious organ dysfunctions (such as severe liver and kidney insufficiency, heart failure, etc.);
• Women who are currently pregnant or lactating;
• History of other tumor diseases in the past;
• Other conditions that the study deems unsuitable for participation in the study, including but not limited to: patients with serious or uncontrollable medical conditions, safety risks, interference with the interpretation of study results, and impact on study compliance.

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

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Shanghai General Hospital — Шанхай

Идентификаторы

NCT: NCT07167264 · PGHD-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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