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

NCT ID: NCT07161921

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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

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Pancreatic Cancer Microbial Colonization Lymph Node Metastasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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lymph node metastasis

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

lymph node metastasis

Intervention Type OTHER

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

non-lymph node metastasis

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

No interventions assigned to this group

Interventions

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lymph node metastasis

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Menghua Dai, Professor

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

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Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PUMCH-PCAMICROBE-3

Identifier Type: -

Identifier Source: org_study_id

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