4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Microbial Diversity of Pancreatic Diseases

Microbial Diversity of Pancreatic Diseases

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
Pancreatic Cancer Pancreatic Diseases

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 tissue are also collected.

Third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.

Then, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Microbial Diversity of Pancreatic Diseases
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 16sRNA and metagenomics [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Collect stool，other digestive secretions，blood and tissue samples and extract DNA.

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male / Female Age ≥ 5 years old, ≤ 75 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.
Criteria

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 history in three months;
  • 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

Contacts
Layout table for location contacts
Contact: Wei WANG 0086-(0)21-64370045 ext 671001 wangwei_0306@163.com

Locations
Layout table for location information
China, Shanghai
Ruijin Hospital
Shanghai, Shanghai, China, 200025
Contact: Wei Wang    +86-13761648121    wangwei_0306@163.com   
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wei WANG Ruijin Hospital
Tracking Information
First Submitted Date December 24, 2018
First Posted Date January 18, 2019
Last Update Posted Date January 18, 2019
Estimated Study Start Date February 1, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2019) 		16sRNA and metagenomics [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microbial Diversity of Pancreatic Diseases
Official Title Microbial Diversity of Pancreatic Diseases
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.
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 tissue are also collected.

Third, the participants were basically divided into three groups，cases with pancreatic cancer, cases with other pancreatic diseases, and health volunteers.

Then, the investigators compare the microflora , its metabolites or effects among the different groups in their stool, digestive secretions, peripheral blood, pancreatic tissues and so on, and hope to identify the potential biomarker and pathogenic mechanisms that causes the onset and progression of pancreatic diseases.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Collect stool，other digestive secretions，blood and tissue samples and extract DNA.
Sampling Method Non-Probability Sample
Study Population

Male / Female Age ≥ 5 years old, ≤ 75 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.
Condition
  • Pancreatic Cancer
  • Pancreatic Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 16, 2019) 		330
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 history in three months;
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Wei WANG 0086-(0)21-64370045 ext 671001 wangwei_0306@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03809247
Other Study ID Numbers pancreatic diseases
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party WeiWang, Ruijin Hospital
Study Sponsor Ruijin Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Wei WANG Ruijin Hospital
PRS Account Ruijin Hospital
Verification Date January 2019

治疗医院

新药特效药

治疗案例

前沿医讯