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Clinical Trials/NCT06411470
NCT06411470
Recruiting
Not Applicable

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

Changhai Hospital1 site in 1 country600 target enrollmentApril 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Changhai Hospital
Enrollment
600
Locations
1
Primary Endpoint
Gastrointestinal microbiota
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiangyu Kong

Principle Investigator

Changhai Hospital

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Gastrointestinal microbiota

Time Frame: 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

Time Frame: up to 2 years

The length of time (in days) from study enrollment that participants remain alive.

Predictive model

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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