Microbial Diversity of Pancreatic Diseases

Sponsor
Ruijin Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03809247
Collaborator
(none)
330
1
58.9
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    330 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Microbial Diversity of Pancreatic Diseases
    Actual Study Start Date :
    Feb 1, 2019
    Anticipated Primary Completion Date :
    Dec 30, 2022
    Anticipated Study Completion Date :
    Dec 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age ≥ 3 years old, ≤ 75 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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Ruijin Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    WeiWang, Chief physician, Ruijin Hospital
    ClinicalTrials.gov Identifier:
    NCT03809247
    Other Study ID Numbers:
    • pancreatic diseases
    First Posted:
    Jan 18, 2019
    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