Microbiota And Metabolites Alterations In Pancreatic Head And Body/Tail Cancer Patients

Study Overview

Microbiota and Metabolites Alterations in Pancreatic Head and Body/Tail Cancer Patients

Pancreatic ductal adenocarcinoma (PDAC) can be divided into pancreatic head cancer (PHC) and pancreatic body/tail cancer (PBTC) according to the anatomical position of tumors. There is increasing evidence that tumors at different sites exhibit different genetic or molecular features and clinical manifestations, and can affect the survival and outcomes of PDAC patients. Studies have shown that the prognosis of PBTC is worse than that of PHC, which is partly attributed to the relatively late clinical presentation of PBTC patients and the lack of overt symptoms such as obstructive jaundice, which is common in PHC. However, it has also been shown that the worse survival of PBTC compared to PHC is not related to the disease stage. Previous studies have investigated the molecular differences between PHC and PBTC and found that the frequency of SMAD4 mutation in PBTC was significantly higher than that in PHC at early stages (I-II). In the late stage (III-IV), PBTC had higher mutation frequency of Kirsten rat sarcoma viral oncogene homolog (KRAS) and mitogen-activated protein kinase (MAPK) pathway, but lower frequency of genomic alterations which can be targeted by drugs. The above genetic and molecular differences may be related to the clinical differences between PHC and PBTC. However, the differences in microbial composition and metabolism between PHC and PBTC have not been fully studied and discussed, and their relationship with clinical manifestations and prognosis is also unclear. In this study, the investigators aimed to analyze the microbial and metabolic differences between PHC and PBTC through 16S ribosomal ribonucleic acid (rRNA) sequencing and untargeted metabolome analysis to further explore the etiology and pathogenesis of PDAC at different anatomical positions.

N/A

Pancreatic Ductal Adenocarcinoma (PDAC)

OTHER: 16S rRNA amplicon sequencing and untargeted metabolomics

2023SDU-QILU-5

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-11-27
First Submitted that Met QC Criteria 2023-11-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-11-30
First Posted (ACTUAL) 2023-11-27	Results First Posted N/A	Last Verified 2023-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Pancreatic head cancer (PHC) tumor tissues	OTHER: 16S rRNA amplicon sequencing and untargeted metabolomics 16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughp
: Pancreatic head cancer (PHC) matched non-tumor tissues	OTHER: 16S rRNA amplicon sequencing and untargeted metabolomics 16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughp
: Pancreatic body/tail cancer (PBTC) tumor tissues	OTHER: 16S rRNA amplicon sequencing and untargeted metabolomics 16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughp
: Pancreatic body/tail cancer (PBTC) matched non-tumor tissues	OTHER: 16S rRNA amplicon sequencing and untargeted metabolomics 16S rRNA sequencing is a method for large-scale identification of community composition, expression abundance, and phylogenetic analysis by polymerase chain reaction (PCR) amplification of specific variable regions of 16S rRNA, combined with high-throughp

Primary Outcome Measures	Measure Description	Time Frame
the abundance of changed microorganisms of PHC and PBTC	Detect the categories and quantities of microorganisms significantly enriched and decreased in the case group.	2023-11-20 to 2023-12-20
the abundance of changed metabolites of PHC and PBTC	Detect the categories and quantities of metabolites significantly upregulated or downregulated in the case group.	2023-11-20 to 2023-12-20

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record