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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2024-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Microbiome Pancreatic Neoplasms 16s RRNA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatic cancer

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

16s rRNA or shotgun metagenomics

Intervention Type DIAGNOSTIC_TEST

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

16s rRNA or shotgun metagenomics

Intervention Type DIAGNOSTIC_TEST

16s rRNA or shotgun metagenomics on oral and fecal samples

Interventions

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16s rRNA or shotgun metagenomics

16s rRNA or shotgun metagenomics on oral and fecal samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No