Integrative Metagenomic and Metabolomic Profiling Identifies Gut Microbiota and Metabolite Signatures Associated With Lymph Node Metastasis in Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- microbiota profiles
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
microbiota profiles
Time Frame: Through the completion of study, an average of 3 years
microbiota profile by metagenomic of the two groups
Secondary Outcomes
- metabolite profiles(Through the completion of study, an average of 3 years)