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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms; Microbiome; 16s RRNA
• Intervention / Treatment: Diagnostic test: 16s rRNA or shotgun metagenomics

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Department of General Surgery, Peking Union Medical College Hospital (PUMCH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a pancreatic tumor detected via imaging

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Menghua Dai, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: fecal microbiome; pancreatic neoplasms; 16s rRNA; oral microbiome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PUMCH-PCAMICROBE-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No