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NCT Number: NCT07167264

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location status: Recruiting

Location contact

Jiang Long, MD

CONTACT

[email protected]

+86 18017317460

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PGHD's AI intelligent model(APP)

Other

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.

Primary outcomes

  1. The incidence and/or improvement rate

    Time frame: 12 months after enrollment

  2. The progression free survival

    Time frame: 12 months after enrollment

  3. The overall survival time

    Time frame: 12 months after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Long Jiang, MD

CONTACT

[email protected]

18017317460

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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