Clinical trial NCT03809247: Microbial Diversity of Pancreatic Diseases
Official title: Microbial Diversity of Pancreatic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Pancreatic Disease
Keywords: Pancreatic cancer
Pancreatic Disease
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 330
Sex: ALL
Minimum age (years): 3
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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;

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

Primary outcomes:
measure: 16sRNA and metagenomics
timeFrame: 12/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Wei WANG, Dr.
role: PRINCIPAL_INVESTIGATOR
References: