Pancreatic Cancer
Conditions
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.
Interventions
OTHERPGHD'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.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLong Jiang, MD
Outcome results
None listed