Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis.

October 22, 2024 updated by: Li Tian, MD, The Third Xiangya Hospital of Central South University

The goal of this observational study is to use endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) to investigate the intratumoral microbiome profile in patients with pancreatic ductal adenocarcinoma (PDAC) and to evaluate its potential impact on tumor diagnosis and prognosis. PDAC is the most common and lethal type of pancreatic cancer, accounting for over 85% of all pancreatic cancer cases. Given that most patients are diagnosed at an advanced stage when surgery is no longer an option, EUS-FNB serves as a crucial and minimally invasive method for accessing and analyzing the microbiome within the tumor.

The main questions this study aims to answer are:

Can EUS-FNB reliably and accurately detect the microbiome within PDAC tumors?

Researchers will analyze tissue samples obtained through EUS-FNB to confirm its ability to accurately capture the diversity and composition of the tumor microbiome.

Are there specific microbes or metabolites within the PDAC tumor microbiome that are linked to patient prognosis or response to chemotherapy?

The study will screen for and identify key microbial species or metabolites associated with treatment outcomes and patient survival in PDAC.

To ensure the reliability of the EUS-FNB results, researchers will systematically compare microbiome data obtained from EUS-FNB samples with those from surgical biopsies of pancreatic cancer tissue. This comparison will help validate the consistency and accuracy of the two methods in identifying the microbiome diversity and composition, confirming the clinical and research utility of EUS-FNB.

Participant Requirements:

Participants will be patients diagnosed with PDAC who require EUS-FNB as part of their clinical assessment and treatment pathway.

During the EUS-FNB procedure, researchers will use the remaining tissue after rapid on-site evaluation (ROSE) to conduct microbiome sequencing, ensuring sample quality.

All participants will provide informed consent, allowing the use of leftover tissue for microbiome analysis, and their privacy will be strictly protected throughout the study.

Study Procedures:

Participants will undergo a standard EUS-FNB procedure as part of their routine clinical care, with no additional procedures required for the study.

Researchers will compare the microbiome characteristics from EUS-FNB samples with those from surgical biopsy samples to verify consistency.

The study will utilize 2bRAD-M metagenomic sequencing technology, which is cost-effective and suitable for low-biomass, host-contaminated, and degraded microbiome samples. This method generates an accurate species-level taxonomic profile for analysis.

By identifying key microbial components or metabolites linked to patient prognosis or treatment response, this study aims to provide scientific evidence for early detection strategies and effective treatment plans for PDAC patients, potentially bringing significant clinical benefits.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Hunan, Hunan, China, 410000
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

At the Third Xiangya Hospital of Central South University, patients with pancreatic diseases requiring diagnosis through EUS-FNB.

Description

Inclusion Criteria:

  1. Males or females aged between 18 and 80 years.
  2. Patients with pancreatic lesions confirmed through imaging examinations (US, MRI, CT, or PET-CT) with a high suspicion of pancreatic ductal adenocarcinoma (PDAC) who require EUS-FNB for diagnostic assistance.
  3. Patients who have not received any chemotherapy, including neoadjuvant, postoperative adjuvant, or palliative chemotherapy.
  4. Patients who agree to participate in this study and sign an informed consent form.

Exclusion Criteria:

  1. Poor physical condition, including but not limited to hemoglobin ≤ 8.0 g/dl, severe cardiopulmonary insufficiency, etc.
  2. Coagulation disorders (platelet count < 50 × 10^9/L, international normalized ratio > 1.5).
  3. Failed anesthesia evaluation.
  4. Acute pancreatitis within the past 2 weeks.
  5. Pregnant or breastfeeding individuals.
  6. Mental illness, drug addiction, or other conditions that may affect follow-up.
  7. Patients who have received antibiotic treatment before the biopsy procedure or other conditions deemed unsuitable by the investigators.

Study Plan

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

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Microbiome Diversity and Abundance Between Pancreatic Ductal Adenocarcinoma (PDAC) and Non-Cancerous Tissues
Time Frame: 2 years
Using 2bRAD-M metagenomic sequencing technology, the study measures and compares bacterial species, quantity, and diversity between PDAC and non-cancerous tissues. This analysis evaluates the relationship between these microbial characteristics and the occurrence and progression of PDAC, aiming to uncover the potential role of the microbiome in the disease process.
2 years

Collaborators and Investigators

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

Sponsor

The Third Xiangya Hospital of Central South University

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 Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

May 30, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fu3tianli4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not plan to make IPD avaliable

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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