NCT03809247

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 24, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

5.5 years

First QC Date

December 24, 2018

Last Update Submit

June 13, 2023

Conditions

Pancreatic CancerPancreatic Disease

Keywords

Pancreatic cancerPancreatic Disease

Outcome Measures

Primary Outcomes (1)

  • 16sRNA and metagenomics

    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

Study Arms (2)

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.

Eligibility Criteria

Age3 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Collect stool，other digestive secretions，blood and tissue samples ( (including paraffin section) and extract DNA .

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System Diseases

Study Officials

  • Wei WANG, Dr.

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

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 24, 2018

First Posted

January 18, 2019

Study Start

February 1, 2019

Primary Completion

July 30, 2024

Study Completion

December 31, 2025

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

CN(1)