Retrospective Study on Microbial Diversity in Paraffin Tissue of Pancreatic Diseases

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05193162
Collaborator
(none)
480
1
60
8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No any intervention

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 2019, 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 Design

Study Type:
Observational
Anticipated Enrollment :
480 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197 Ruijin Road II, Shanghai 200025, China
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jul 31, 2026

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 16sRNA and metagenomics [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age ≥ 5 years old, ≤ 75 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ruijin Hospital Shanghai China 200025

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    WeiWang, Chief physician, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT05193162
    Other Study ID Numbers:
    • (2021)Clin. Ethics Appr. (257)
    First Posted:
    Jan 14, 2022
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by WeiWang, Chief physician, Ruijin Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 14, 2022