Investigating the microbiome in pancreatic cancer tumors using biopsy samples
Profiling the Intratumoral Microbiome of Pancreatic Ductal Adenocarcinoma Based on EUS-FNB Tissue Samples and Exploring Its Impact on Tumor Diagnosis and Prognosis.
This study is testing if taking small tissue samples from pancreatic cancer tumors can help us understand the different microbes present and how they might affect diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hunan, Hunan) |
| Trial ID | NCT06655233 on ClinicalTrials.gov |
What this trial studies
This observational study aims to profile the intratumoral microbiome in patients diagnosed with pancreatic ductal adenocarcinoma (PDAC) using endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). By analyzing tissue samples obtained through EUS-FNB, the study seeks to determine the reliability of this method in capturing the diversity and composition of the tumor microbiome. Additionally, it will explore the potential impact of specific microbes or metabolites on tumor diagnosis and prognosis, which could enhance understanding of PDAC.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with pancreatic lesions highly suspected to be PDAC who require EUS-FNB for diagnosis.
Not a fit: Patients with severe physical conditions, coagulation disorders, or those who have received prior antibiotic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for pancreatic cancer patients.
How similar studies have performed: While the approach of profiling the microbiome in tumors is gaining interest, this specific application in PDAC using EUS-FNB is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hunan, Hunan
- The Third Xiangya Hospital of Central South University — Hunan, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Li Tian
- Email: f3tianli@outlook.com
- Phone: 0731-13574843423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.