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NCT06411470 Clinical Trial

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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06411470
Other study ID # CHEC2024-149
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 20, 2024
Est. completion date December 31, 2025

Study information
Verified date May 2024
Source Changhai Hospital
Contact Xiangyu Kong, MD
Phone 13564644397
Email xiangyukong185@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
China Changhai Hospital Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum metabolites 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. Baseline
Primary Gastrointestinal microbiota 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. Baseline
Primary Overall Survival The length of time (in days) from study enrollment that participants remain alive. up to 2 years
Primary Predictive model 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. up to 2 years
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