Gastrointestinal Microflora and Serum Metabolomics in Patients With Pancreatic Cancer and Chronic Pancreatitis

Recruiting

• Conditions: Chronic Pancreatitis; Pancreatic Cancer

• Registration Number: NCT06411470
• Lead Sponsor: Changhai Hospital

Brief Summary

The investigators plan to collect throat swabs, saliva, feces and serum samples from pancreatic cancer patients, chronic pancreatitis patients and healthy people and clarify the characteristics of oral flora and serum metabolome of pancreatic cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-20
• Status Verified: 2024-05
• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1.Pathologic diagnosis of pancreatic ductal adenocarcinoma；Diagnosis of CP defined as having obvious morphological features of CP (i.e., the presence of pancreatic calcifications on CT scan and/or magnetic resonance cholangiopancreatography)；Other benign disease populations without pancreatic lesions.

Exclusion Criteria

1. Pregnant women.
2. Patients with coagulation disorders who are unable to undergo blood tests.
3. Have a history of using antibiotics or probiotics within the past 3 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastrointestinal microbiota	Baseline	Perform 16S RNA sequence and shotgun metagenomic analysis of fecal, throat swabs and salivary samples collected from pancreatic cancer patients, chronic pancreatitis patients and healthy people.
Overall Survival	up to 2 years	The length of time (in days) from study enrollment that participants remain alive.
Predictive model	up to 2 years	Combined with preoperative imaging and pathological information, a predictive model of pancreatic cancer would be established based on the metabolic and microbiota difference. Verify the stability and accuracy of our model in larger cohorts and promote clinical translation.
serum metabolites	Baseline	Perform Untargeted liquid chromatography-tandem mass spectrometry (LC-MS/MS) to analyse serum samples collected from pancreatic cancer patients, chronic pancreatitis patients and healthy people.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China