NCT07167264

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
1mo left

Started Jul 2025

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jul 2025May 2026

Study Start

First participant enrolled

July 16, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 2, 2025

Last Update Submit

September 10, 2025

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (3)

  • The incidence and/or improvement rate

    12 months after enrollment

  • The progression free survival

    12 months after enrollment

  • The overall survival time

    12 months after enrollment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Other: PGHD's AI intelligent model(APP)

Control group

NO INTERVENTION

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

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Long Jiang, MD

CONTACT

18017317460jiang.long@shgh.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of pancreatic surgery

Study Record Dates

First Submitted

September 2, 2025

First Posted

September 11, 2025

Study Start

July 16, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

CN(1)