Gut Microbiota and Metabolite Signatures Associated With Lymph Node Metastasis in Pancreatic Cancer

NCT07161921 | Completed

• 1 other identifier: PUMCH-PCAMICROBE-3
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the association between gut microbiota and lymph node metastasis (LNM) in pancreatic cancer. While gut microbial dysbiosis has been linked to pancreatic cancer development and distant metastasis, its role in LNM remains unclear. By comparing the gut microbiota and metabolite profiles of patients with and without LNM, the study aims to identify key microbial and metabolic signatures linked to metastasis. Additionally, predictive models will be developed to facilitate preoperative identification of high-risk patients, with the goal of improving clinical decision-making and treatment planning.

Conditions

Pancreatic Cancer; Microbial Colonization; Lymph Node Metastasis

Keywords

pancreatic cancer; microbiome; metabolite; lymph node metastasis

Outcome Measures

Primary Outcomes (1)

• microbiota profiles

  microbiota profile by metagenomic of the two groups

  Through the completion of study, an average of 3 years

Secondary Outcomes (1)

• metabolite profiles

  Through the completion of study, an average of 3 years

Study Arms (2)

lymph node metastasis

Histopathological examination confirmed the presence of at least one lymph node metastasis

Other: lymph node metastasis

non-lymph node metastasis

Histopathological examination confirmed the absence of at least one lymph node metastasis

Interventions

lymph node metastasis OTHER

Histopathological examination confirmed the presence of at least one lymph node metastasis

lymph node metastasis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with pancreatic cancer and received radical surgery

You may qualify if:

• years
• Agree to participate in the study

You may not qualify if:

• A prior diagnosis of other malignancies, infectious diseases, psychiatric or neurodegenerative disorders, or conditions affecting the oral or gastrointestinal systems;
• Recent medical treatments or procedures within specific time frames, including: (a) Use of antibiotics, hormone therapy, or immunosuppressive agents within the past three months. (b) Undergoing gastrointestinal reconstructive surgery within the past three months. (c) Regular use of laxatives, antidiarrheal medications, or high-dose probiotics within the past month. (d) Participation in gastrointestinal examinations within the past three days

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

metagenomics of microbiome

MeSH Terms

Conditions

Pancreatic Neoplasms; Communicable Diseases; Lymphatic Metastasis

Interventions

lncRNA LNMAT1, human

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Neoplastic Processes

Study Officials

• Menghua Dai, Professor

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: September 9, 2025
• Study Start: May 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)