Pancreatic CancerNCT05193162
Retrospective Study on Microbial Diversity in Paraffin Tissue of Pancreatic Diseases
An observational study of Pancreatic Cancer and Pancreatic Disease, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 85 years
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Disease, Microbial Colonization
- What is being tested?
- No any intervention
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Wei Wang, Dr., +86-13761648121, wangwei_0306@163.com
About this study
Official title: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197 Ruijin Road II, Shanghai 200025, China
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.
Read the detailed description
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.
- Being tested
- No any intervention
- Keywords
- Pancreatic cancer, Pancreatic Diseases, Microbial Colonization
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No any interventionOther
Also called have no any intervention
have no any intervention
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic ductal adenocarcinoma | According to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: No any intervention | |
| Blank paraffin section | Not described Receives: Other: No any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Feb 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WeiWang, Ruijin Hospital
- Investigators
- Wei Wang, Dr., Study chair, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University，No. 197 Ruijin Road II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193162
- Sponsor's protocol ID
- (2021)Clin. Ethics Appr. (257)
- Status last verified
- Jun 2023
- First submitted
- 31 Dec 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197 Ruijin Road II, Shanghai 200025, China
- ClinicalTrials.gov ID
- NCT05193162
- Acronym / sponsor ID
- (2021)Clin. Ethics Appr. (257)
- Keywords
- Pancreatic cancer, Pancreatic Diseases, Microbial Colonization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Pancreatic ductal adenocarcinoma | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Chronic pancreatitis | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Pancreatic serous cystadenoma | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Pancreatic mucinous cystadenoma | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Intraductal papillary mucinous tumor | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Pancreatic neuroendocrine tumor | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Pancreatic acinar cell carcinoma | – | Other: No any interventionAccording to the relevant information such as clinical features and prognosis, it may continue to be divided into several subgroups. |
| Solid pseudopapillary tumor of pancreas | – | Other: No any interventionAccording 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 |
Who may qualify
- Ages
- 5 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No any interventionAlso: have no any interventionhave no any intervention | Other | Blank paraffin section, Chronic pancreatitis, Intraductal papillary mucinous tumor, Pancreatic acinar cell carcinoma, Pancreatic ductal adenocarcinoma, Pancreatic mucinous cystadenoma, Pancreatic neuroendocrine tumor, Pancreatic serous cystadenoma, Solid pseudopapillary tumor of pancreas |
Primary outcome
16sRNA and metagenomics
Time frame: 7/2026
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang, Dr. study chair
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University，No. 197 Ruijin Road II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreatic Disease, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Wang, Dr. (+86- 13761648121, wangwei_0306@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16sRNA and metagenomics (time frame: 7/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.