Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655233
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None