MedDataX Logo

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

NCT ID: NCT06147154

Last Updated: 2023-11-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Ductal Adenocarcinoma (PDAC)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pancreatic head cancer (PHC) tumor tissues

16S rRNA amplicon sequencing and untargeted metabolomics

Intervention Type OTHER

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-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity.

Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.

Pancreatic head cancer (PHC) matched non-tumor tissues

16S rRNA amplicon sequencing and untargeted metabolomics

Intervention Type OTHER

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-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity.

Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.

Pancreatic body/tail cancer (PBTC) tumor tissues

16S rRNA amplicon sequencing and untargeted metabolomics

Intervention Type OTHER

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-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity.

Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.

Pancreatic body/tail cancer (PBTC) matched non-tumor tissues

16S rRNA amplicon sequencing and untargeted metabolomics

Intervention Type OTHER

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-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity.

Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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-throughput sequencing and bioinformatics analysis. It also enables large-scale identification of the entire flora in a given habitat to study microbial diversity.

Untargeted metabolomics refers to the use of Liquid Chromatograph Mass Spectrometer (LC-MS), Gas Chromatograph Mass Spectrometer (GC-MS), and nuclear magnetic resonance (NMR) technology. The dynamic changes of small molecular metabolites in cells, tissues, organs or organisms before and after stimulation or disturbance were detected without bias. The differential metabolites were screened by bioinformatics analysis, and the pathway analysis of differential metabolites was performed to reveal the physiological mechanism of their changes.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Participants aged above 18 years.
2. Patients who signed informed consent.
3. PDAC patients diagnosed via postoperative pathology.

Exclusion Criteria

1. Comorbidity with other cancers.
2. Underwent preoperative chemotherapy, radiotherapy, or other biological treatment.
3. Use of antibiotics, probiotics or prebiotics in the previous month.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023SDU-QILU-5

Identifier Type: -

Identifier Source: org_study_id