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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: 16s RRNA; Microbiome; Pancreatic Neoplasms

Treatments: Diagnostic Test: 16s rRNA or shotgun metagenomics

Study type: Observational

Funder types: Other

Identifiers

NCT06659237

PUMCH-PCAMICROBE-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

121 participants in 2 patient groups

Pancreatic cancer

Description:

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

Treatment:

Diagnostic Test: 16s rRNA or shotgun metagenomics

Benign or low-grade malignant pancreatic tumor

Description:

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

Treatment:

Diagnostic Test: 16s rRNA or shotgun metagenomics