Microbial Diversity of Pancreatic Diseases

June 13, 2023 updated by: WeiWang, Ruijin Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

330

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

3 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Male / Female Age ≥ 3 years old, ≤ 85 years old;

  • After MDT discussion, routine surgery can be performed, and the postoperative pathology is clear as pancreatic cancerand other pancreatic diseases;
  • No history of antibiotics for three months before surgery, no history of yogurt containing probiotics.
  • There is no serious damage to heart, liver and kidney function.
  • After obtaining the consent and specimen collection, detailed screening found that some cases with history of antibiotics or yogurt history in three months. This part of the specimen was not discarded. As a second candidate research objects to study the effect of antibiotics or yoghurt on the flora in the disease state.

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pancreatic cancer
such as Pancreatic ductal adenocarcinoma, Pancreatic acinar adenocarcinoma, and so on.
Other pancreatic diseases
such as chronic pancreatitis, Intraductal papillary mucinous neoplasm (IPMN); Solid pseudopapillary tumors (SPT); Serous cystic neoplasm (SCN); Pancreatic neuroendocrine neoplasm (P-NN); Mucinous cystic neoplasm (MCN) and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16sRNA and metagenomics
Time Frame: 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.
12/2022

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Wei WANG, Dr., Ruijin Hospital

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 Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Estimated)

July 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 24, 2018

First Submitted That Met QC Criteria

January 16, 2019

First Posted (Actual)

January 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pancreatic diseases

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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