Retrospective Study on Microbial Diversity in Paraffin Tissue of Pancreatic Diseases

June 13, 2023 updated by: WeiWang, Ruijin Hospital

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197 Ruijin Road II, Shanghai 200025, China

The great harm of pancreatic diseases and the unknown etiology and pathogenesis make it difficult to intervene in most early cases in time. Previous studies by scholars and applicants at home and abroad have shown that the microflora in pancreatic tissue is closely related to chronic pancreatitis and pancreatic cancer. However, the research on the mechanism of microbial diversity in pancreatic tissue and the occurrence and development of various pancreatic diseases has not been reported. Based on the previous research, this subject continues to take various pancreatic diseases as the research object based on the database of pancreatic center and pathology department of Ruijin Hospital Affiliated to Medical College of Shanghai Jiaotong University, To explore the characteristics of microbial flora in pancreas in different pancreatic diseases and its mechanism of influence on disease microenvironment. Select specific microbial flora or targets in the pancreas for various pancreatic diseases, so as to provide new theoretical basis and practical guidance for the early diagnosis and treatment of pancreatic diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

AIMS:

To explore the correlation between the characteristics of microbial flora in pancreas and clinical and pathological characteristics of patients with various pancreatic diseases; To clarify the similarities and differences of microbial flora in pancreas in different pancreatic diseases; Select the specific microbial flora or targets in the pancreas for various pancreatic diseases; To provide a new theoretical basis and practical guidance for the early diagnosis, treatment and prognosis of pancreatic diseases.

METHODS:

（1）Patients with various pancreatic diseases operated from January 2005 to June 2022, including but not limited to: pancreatic ductal adenocarcinoma, chronic pancreatitis, pancreatic serous cystadenoma, pancreatic mucinous cystadenoma, intraductal papillary mucinous tumor, pancreatic neuroendocrine tumor, pancreatic acinar cell carcinoma, solid pseudopapillary tumor of pancreas and other pancreatic diseases.

(2) According to the database of Ruijin Hospital, about 30 age and sex matched cases were selected for each pancreatic disease.

(3) All the participants provided written informed consent for participating in the study. If the patient dies, there is an ethical exemption. The collecting procedures have no intervention or impact on treatment measures.

(4)The lesion tissue and adjacent pancreatic tissue were obtained from the paraffin tissue made from the surgical specimens for sampling.

(5)High throughput sequencing was performed according to the instructions of 16S rRNA gene sequencing kit or macro gene detection kit. Anosim (analysis of similarities) statistical method was used for similarity analysis to analyze the correlation between microbiota differences and patients' clinical characteristics (including but not limited to various clinical symptoms, serological indexes, tumor stage, prognosis, and human whole exon sequencing, etc.), pathological type and grade, whether to transfer or not.

(6)According to the instructions of immunohistochemical detection and immunofluorescence detection, the relative abundance and localization of microorganisms in different pancreatic tissues of different pancreatic diseases in different cells (tumor cells, immune cells, normal pancreatic acinar cells, duct cells, etc.) were detected.

Study Type

Observational

Enrollment (Estimated)

800

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, 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

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

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Male / Female, Age ≥ 5 years old, ≤ 85 years old; - After MDT discussion, routine surgery can be performed, and the postoperative pathology is clear as pancreatic cancer and 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.

Description

Inclusion Criteria:

  • Age ≥ 5 years old, ≤ 85 years old;
  • After MDT discussion, routine surgery can be performed, and the postoperative pathology is clear as pancreatic cancer and 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.

Exclusion Criteria:

  • Antibiotics or yogurt containing probiotics history in three months;
  • 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.

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
Intervention / Treatment
Pancreatic ductal adenocarcinoma
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Chronic pancreatitis
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Pancreatic serous cystadenoma
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Pancreatic mucinous cystadenoma
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Intraductal papillary mucinous tumor
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Pancreatic neuroendocrine tumor
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Pancreatic acinar cell carcinoma
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Solid pseudopapillary tumor of pancreas
According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups.
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention
Blank paraffin section
Other: No any intervention
have no any intervention
Other Names:
  • have no any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
16sRNA and metagenomics
Time Frame: 7/2026
To obtain intestinal microbial information in patients with pancreatic cancer and other pancreatic diseases, to obtain microbial community structure, evolutionary relationship and information on microbial and environmental correlation in the intestinal environmental samples (weight unit: gram). The patient's microbiological characteristics were correlated with the patient's clinical characteristics and prognosis, so as to obtain the relevant biomarker information.
7/2026

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Study Chair: Wei Wang, Dr., Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University，No. 197 Ruijin Road II

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)

December 31, 2023

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

December 31, 2021

First Submitted That Met QC Criteria

December 31, 2021

First Posted (Actual)

January 14, 2022

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

  • (2021)Clin. Ethics Appr. (257)

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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