NCT07161921

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

Integrative Metagenomic and Metabolomic Profiling Identifies Gut Microbiota and Metabolite Signatures Associated With Lymph Node Metastasis in Pancreatic Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pancreatic cancer is one of the most aggressive malignancies of the digestive system, characterized by an insidious onset, early lymph node metastasis (LNM), poor prognosis, and resistance to chemotherapy and radiotherapy. LNM is recognized as an independent prognostic factor affecting patient survival. Dysbiosis of the gut microbiota has been implicated in cancer development and progression by influencing metabolic and immune functions. Previous studies demonstrated that gut microbiota is altered in patients with pancreatic cancer, and microbial signatures may serve as potential diagnostic markers. Moreover, gut microbiota has been reported to predict distant metastasis in pancreatic cancer patients. However, the relationship between gut microbiota and lymph node metastasis in pancreatic cancer remains unexplored. This study aims to characterize the differences in gut microbial composition between pancreatic cancer patients with and without LNM, identify key microbial taxa and metabolites associated with LNM, and elucidate their potential roles in mediating metastasis. Furthermore, we seek to develop predictive models based on microbiome and metabolite profiles for LNM to facilitate preoperative identification of high-risk patients, ultimately optimizing clinical decision-making and therapeutic strategies.

Conditions

• Pancreatic Cancer
• Microbial Colonization
• Lymph Node Metastasis

Interventions

Type	Name	Description
OTHER	lymph node metastasis	Histopathological examination confirmed the presence of at least one lymph node metastasis

Timeline

• Start date: 2021-05-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: China