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

Launched by THE THIRD XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying pancreatic ductal adenocarcinoma (PDAC), the most common and serious type of pancreatic cancer. Researchers want to understand the bacteria and other microbes that live within these tumors by using a method called endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB). This technique is a safe and minimally invasive way to collect tissue samples from the tumor, which will help them see if specific microbes are linked to how the disease behaves and how patients respond to treatment.

To participate, patients need to be between 18 and 80 years old, have suspected PDAC based on imaging tests, and must not have started chemotherapy yet. During the EUS-FNB procedure, they will collect tissue samples, which will be analyzed alongside surgical biopsy samples to ensure accuracy. Participants will be closely monitored, and their privacy will be respected throughout the study. Ultimately, the goal is to find better ways to diagnose and treat pancreatic cancer, potentially improving outcomes for patients.

Gender

ALL

Eligibility 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.