Fecal And Oral Microbiota Between Pancreatic Cancer And Benign/Low-grade Malignant Tumor Patients

Study Overview

Fecal and Oral Microbiota Between Pancreatic Cancer and Benign/Low-grade Malignant Tumor Patients

Significant gaps exist in understanding the gastrointestinal microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze these microbiota characteristics and explore their potential use in distinguishing malignant pancreatic lesions.

In the past decade, microbiome research has rapidly progressed, revealing the critical roles of fecal and oral microbiota in maintaining internal homeostasis. Studies employing 16S rRNA and metagenomics have highlighted dysbiosis of the fecal and oral microbiota as closely linked to PCA development and progression. However, significant gaps exist in understanding the fecal and oral microbiota in patients with pancreatic cancer (PCA) versus benign or low-grade malignant pancreatic tumors (NPCA). This study aimed to analyze fecal and oral microbiota characteristics, and to establish classifiers to discriminate PCA from NPCA, providing a reference for early clinical identification of malignant tumors.

Microbiome
Pancreatic Neoplasms
16s RRNA

DIAGNOSTIC_TEST: 16s rRNA or shotgun metagenomics

PUMCH-PCAMICROBE-2

Study Record Dates

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
First Submitted 2024-10-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-10-23
First Submitted that Met QC Criteria 2024-10-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-10-26
First Posted (ACTUAL) 2024-10-26	Results First Posted N/A	Last Verified 2024-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Pancreatic cancer Patients pathologically diagnosed with cancer or high-grade mucinous tumors based on surgical specimens or puncture samples	DIAGNOSTIC_TEST: 16s rRNA or shotgun metagenomics 16s rRNA or shotgun metagenomics on oral and fecal samples
: Benign or low-grade malignant pancreatic tumor Patients with pathological diagnoses such as low-grade intraductal papillary mucinous neoplasm (IPMN), mucinous cystadenoma, serous cystadenoma, chronic pancreatitis, neuroendocrine tumors, or solid pseudopapillary tumors	DIAGNOSTIC_TEST: 16s rRNA or shotgun metagenomics 16s rRNA or shotgun metagenomics on oral and fecal samples

Participant Group/Arm

Intervention/Treatment

: Pancreatic cancer

Patients pathologically diagnosed with cancer or high-grade mucinous tumors based on surgical specimens or puncture samples

DIAGNOSTIC_TEST: 16s rRNA or shotgun metagenomics

16s rRNA or shotgun metagenomics on oral and fecal samples

: Benign or low-grade malignant pancreatic tumor

Patients with pathological diagnoses such as low-grade intraductal papillary mucinous neoplasm (IPMN), mucinous cystadenoma, serous cystadenoma, chronic pancreatitis, neuroendocrine tumors, or solid pseudopapillary tumors

DIAGNOSTIC_TEST: 16s rRNA or shotgun metagenomics

16s rRNA or shotgun metagenomics on oral and fecal samples

Primary Outcome Measures	Measure Description	Time Frame
the accuracy of the diagnostic classifier	we used random forest algorithm to construct oral and fecal microbiome classifiers to discriminate PCA and NPCA. AUC value was used to evaluate the efficacy of the classifiers	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:
18 Years

Accepts Healthy Volunteers:

Patients with a pancreatic tumor detected via imaging with no prior treatment before sample collection
Patients volunteer to provide oral and fecal samples

Current or previous diagnoses of (a) other malignancies, (b) infectious diseases, (c) oral or gastrointestinal disorders (d) psychiatric or neurodegenerative disorders
Specific medical procedures or interventions within defined periods, including (a) antibiotic, hormone therapy, or immunosuppressant within the past three months, (b) gastrointestinal reconstructive surgery within the past three months, (c) frequent use of cathartics, antidiarrheals, or therapeutic doses of probiotics within the past month, (d) oral or gastrointestinal examinations within the past three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Menghua Dai, MD, Peking Union Medical College Hospital

Publications

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

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Clinical Trial Record