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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Lymph Node Metastasis
Microbial Colonization
Pancreatic Cancer

Treatments

Other: lymph node metastasis

Study type

Observational

Funder types

Other

Identifiers

NCT07161921
PUMCH-PCAMICROBE-3

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

55 participants in 2 patient groups

lymph node metastasis
Description:
Histopathological examination confirmed the presence of at least one lymph node metastasis
Treatment:
Other: lymph node metastasis
non-lymph node metastasis
Description:
Histopathological examination confirmed the absence of at least one lymph node metastasis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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