Pancreatic CancerNCT06655233
Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis.
An observational study of Pancreatic Cancer and EUS-FNB, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer, EUS-FNB, Intratumoral Microbiota
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At the Third Xiangya Hospital of Central South University, patients with pancreatic diseases requiring diagnosis through EUS-FNB.
Who may be able to join
- Males or females aged between 18 and 80 years.
- 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.
- Patients who have not received any chemotherapy, including neoadjuvant, postoperative adjuvant, or palliative chemotherapy.
- Patients who agree to participate in this study and sign an informed consent form.
Who cannot join
- Poor physical condition, including but not limited to hemoglobin ≤ 8.0 g/dl, severe cardiopulmonary insufficiency, etc.
- Coagulation disorders (platelet count < 50 × 10^9/L, international normalized ratio > 1.5).
- Failed anesthesia evaluation.
- Acute pancreatitis within the past 2 weeks.
- Pregnant or breastfeeding individuals.
- Mental illness, drug addiction, or other conditions that may affect follow-up.
- Patients who have received antibiotic treatment before the biopsy procedure or other conditions deemed unsuitable by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Hunan, Hunan, 410000
Li Tian, 0731-17773669813, xiayumoo009@outlook.com
About this study
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:
Read more
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.
- Conditions
- Pancreatic Cancer, EUS-FNB, Intratumoral Microbiota, Diagnosis, Prognosis
- Keywords
- pancreatic cancer, EUS-FNB, intratumoral microbiota, diagnosis, Prognosis
- Medical subject headings
- Pancreatic Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Microbiome Diversity and Abundance Between Pancreatic Ductal Adenocarcinoma (PDAC) and Non-Cancerous Tissues
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Tian, MD, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655233
- Sponsor's protocol ID
- fu3tianli4
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not plan to make IPD avaliable
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06655233
- Acronym / sponsor ID
- fu3tianli4
- Conditions
- Pancreatic Cancer, EUS-FNB, Intratumoral Microbiota, Diagnosis, Prognosis
- Keywords
- pancreatic cancer, EUS-FNB, intratumoral microbiota, diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At the Third Xiangya Hospital of Central South University, patients with pancreatic diseases requiring diagnosis through EUS-FNB.
Key inclusion criteria (4 listed)
- Males or females aged between 18 and 80 years.
- 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.
- Patients who have not received any chemotherapy, including neoadjuvant, postoperative adjuvant, or palliative chemotherapy.
- Patients who agree to participate in this study and sign an informed consent form.
Key exclusion criteria (7 listed)
- Poor physical condition, including but not limited to hemoglobin ≤ 8.0 g/dl, severe cardiopulmonary insufficiency, etc.
- Coagulation disorders (platelet count < 50 × 10^9/L, international normalized ratio > 1.5).
- Failed anesthesia evaluation.
- Acute pancreatitis within the past 2 weeks.
- Pregnant or breastfeeding individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: No. There is not plan to make IPD avaliable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and EUS-FNB, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Tian (0731-13574843423, f3tianli@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Microbiome Diversity and Abundance Between Pancreatic Ductal Adenocarcinoma (PDAC) and Non-Cancerous Tissues (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.