Microbial Diversity of Pancreatic Diseases

Recruiting

• Conditions: Pancreatic Cancer; Pancreatic Disease

• Registration Number: NCT03809247
• Lead Sponsor: Ruijin Hospital

Brief Summary

This study plans to analyze the digestive flora structure of the group of patients with pancreatic cancer.

The investigators compared the microflora of pancreatic cancer with other pancreatic diseases and healthy people，in order to obtatin the information of microbial community difference among the different groups. Finally，the investigators hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

Detailed Description

First, all the participants provided written informed consent for participating in the study. And the collecting procedures have no intervention or impact on treatment measures.

Second,the samples are collected, including the stools, the peripheral blood, and other digestive secretions. If the participants had surgical indications and received surgical treatment, the surgical resections of tissues (including paraffin section) are also collected.

Third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.

Finally, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues ( (including paraffin section)) and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

Study Timeline

• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Study Start: 2019-02-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15
• Primary Completion: 2024-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Age ≥ 3 years old, ≤ 85 years old;
• After MDT discussion, routine surgery or ERCP can be performed, and the postoperative pathology is clear as pancreatic cancer and other pancreatic diseases;
• There is no serious damage to heart, liver and kidney function;

Exclusion Criteria

• Women who are breast-feeding during pregnancy and after pregnancy;
• Patients with evidence of sensory or motor neuropathy;
• Those who have a clear cardiovascular disease, severe associated disease or active infection, including known HIV infection;
• Those who have a history of other cancers;
• Those who are allergic to drugs or their excipients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
16sRNA and metagenomics	12/2022	Obtain intestinal microbial information from patients with pancreatic cancer and other pancreatic diseases, and obtain information on microbial community structure, evolutionary relationships, and microbial and environmental correlations in intestinal environment samples(weight in grams).; Correlate the patient's microbial profile with the pathogenesis of the patient to obtain biomarkers related to the pathogenesis.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China