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2019-02-01
2023-12-31
2026-07-31
800
NCT05193162
Ruijin Hospital
Ruijin Hospital
OBSERVATIONAL
Retrospective Study on Microbial Diversity in Paraffin Tissue of Pancreatic Diseases
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.
AIMS: To explore the correlation between the characteristics of microbial flora in pancreas and clinical and pathological characteristics of patients with various pancreatic diseases; To clarify the similarities and differences of microbial flora in pancreas in different pancreatic diseases; Select the specific microbial flora or targets in the pancreas for various pancreatic diseases; To provide a new theoretical basis and practical guidance for the early diagnosis, treatment and prognosis of pancreatic diseases. METHODS: （1）Patients with various pancreatic diseases operated from January 2005 to June 2022, including but not limited to: pancreatic ductal adenocarcinoma, chronic pancreatitis, pancreatic serous cystadenoma, pancreatic mucinous cystadenoma, intraductal papillary mucinous tumor, pancreatic neuroendocrine tumor, pancreatic acinar cell carcinoma, solid pseudopapillary tumor of pancreas and other pancreatic diseases. (2) According to the database of Ruijin Hospital, about 30 age and sex matched cases were selected for each pancreatic disease. (3) All the participants provided written informed consent for participating in the study. If the patient dies, there is an ethical exemption. The collecting procedures have no intervention or impact on treatment measures. (4)The lesion tissue and adjacent pancreatic tissue were obtained from the paraffin tissue made from the surgical specimens for sampling. (5)High throughput sequencing was performed according to the instructions of 16S rRNA gene sequencing kit or macro gene detection kit. Anosim (analysis of similarities) statistical method was used for similarity analysis to analyze the correlation between microbiota differences and patients' clinical characteristics (including but not limited to various clinical symptoms, serological indexes, tumor stage, prognosis, and human whole exon sequencing, etc.), pathological type and grade, whether to transfer or not. (6)According to the instructions of immunohistochemical detection and immunofluorescence detection, the relative abundance and localization of microorganisms in different pancreatic tissues of different pancreatic diseases in different cells (tumor cells, immune cells, normal pancreatic acinar cells, duct cells, etc.) were detected.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-12-31 | N/A | 2023-06-13 |
2021-12-31 | N/A | 2023-06-15 |
2022-01-14 | N/A | 2023-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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. | |
| : Blank paraffin section | OTHER: No any intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Wei Wang, Dr. Phone Number: +86- 13761648121 Email: wangwei_0306@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
5 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
