NCT05193162

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2019Jul 2026

Study Start

First participant enrolled

February 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

4.9 years

First QC Date

December 31, 2021

Last Update Submit

June 13, 2023

Conditions

Pancreatic CancerPancreatic DiseaseMicrobial Colonization

Keywords

Pancreatic cancerPancreatic DiseasesMicrobial Colonization

Outcome Measures

Primary Outcomes (1)

  • 16sRNA and metagenomics

    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

Study Arms (9)

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

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

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

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

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

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

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

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

Blank paraffin section

Other: No any intervention

Interventions

No any interventionOTHER

have no any intervention

Also known as: have no any intervention
Blank paraffin sectionChronic pancreatitisIntraductal papillary mucinous tumorPancreatic acinar cell carcinomaPancreatic ductal adenocarcinomaPancreatic mucinous cystadenomaPancreatic neuroendocrine tumorPancreatic serous cystadenomaSolid pseudopapillary tumor of pancreas

Eligibility Criteria

Age5 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collect lesion tissue samples and extract DNA. The lesion tissues were obtained from the paraffin tissues which were made from the surgical specimens for sampling.

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic DiseasesCommunicable Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Wang, Dr.

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

    STUDY CHAIR

Central Study Contacts

Wei Wang, Dr.

CONTACT

+86- 13761648121wangwei_0306@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

February 1, 2019

Primary Completion

December 31, 2023

Study Completion (Estimated)

July 31, 2026

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

CN(1)