Gastrointestinal Microflora And Serum Metabolomics In Patients With Pancreatic Cancer And Chronic Pancreatitis

Study Overview

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

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.

N/A

Pancreatic Cancer
Chronic Pancreatitis

CHEC2024-149

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-05-09
First Submitted that Met QC Criteria 2024-05-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-05-13
First Posted (ACTUAL) 2024-05-13	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: pancreatic cancer Pathologic diagnosis of pancreatic ductal adenocarcinoma
: chronic pancreatitis 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)
: healthy people Other benign disease populations without pancreatic lesions

Primary Outcome Measures	Measure Description	Time Frame
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
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
Overall Survival	The length of time (in days) from study enrollment that participants remain alive.	up to 2 years
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xiangyu Kong, MD

Phone Number: 13564644397

Email: xiangyukong185@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:
1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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General Publications

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Clinical Trial Record