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

NCT ID: NCT07167264

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Patients use the APP to check in daily and record PGHD data, combined with offline routine follow-up, nutritional assessment and intervention.

Group Type: EXPERIMENTAL

PGHD's AI intelligent model(APP)

Intervention Type: 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.

Control group

Patients received routine outpatient follow-up and nutritional assessment by investigator.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age: 18-80 years old, and voluntarily signed the informed consent form to participate in the study;

2. Meet the clinical and pathological diagnostic criteria for pancreatic cancer (ICD-10:C25);

3. After radical surgery, fully recovered from surgery at randomization;

4. ECOG PS score 0-1 ;

5. Have objective conditions to complete follow-up and examination during the study process.

Exclusion Criteria

1. Patients or their families are willing to use the APP;

2. Current history or past history of metastatic or locally recurrent pancreatic cancer;

3. Combined with other serious organ dysfunctions (such as severe liver and kidney insufficiency, heart failure, etc.);

4. Women who are currently pregnant or lactating;

5. History of other tumor diseases in the past;

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jiang Long

Head of pancreatic surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Long Jiang, MD

Role: CONTACT

jiang.long@shgh.cn

18017317460

Facility Contacts

Jiang Long, MD

Role: primary

jiang.long@shgh.cn

+86 18017317460

Other Identifiers

PGHD-2025

Identifier Type: -

Identifier Source: org_study_id