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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07161921
Enrollment
55
Registered
2025-09-09
Start date
2021-05-01
Completion date
2024-09-30
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph Node Metastasis, Microbial Colonization, Pancreatic Cancer

Keywords

pancreatic cancer, microbiome, metabolite, lymph node metastasis

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.

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.

Interventions

OTHERlymph node metastasis

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

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 18-75 years * Agree to participate in the study

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
microbiota profilesThrough the completion of study, an average of 3 yearsmicrobiota profile by metagenomic of the two groups

Secondary

MeasureTime frameDescription
metabolite profilesThrough the completion of study, an average of 3 yearsmetabolite profile by metabolomic of the two groups

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026