Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS
- Conditions
- Pancreatic Cancer
- Interventions
- Procedure: Endoscopic ultrasound-guided protal venous blood sampling
- Registration Number
- NCT03821909
- Lead Sponsor
- Ying Lv
- Brief Summary
The investigators are going to explore the diagnostic and prognostic value of circulating tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic ultrasound in pancreatic cancer patients.
- Detailed Description
As the prognosis of pancreatic cancer, a kind of malignant tumor, remains poor due to the low diagnostic rate at the early stage, there is still a significant clinical need to determine individualized tumor molecular profiles and personalized risk for recurrence. Circulating tumor cells (CTCs) and exosomes from patients with primary tumors may hold promise in serving as an informative biomarker to address this clinical need. Here in this study, the investigators are going to explore the feasibility and safety of sampling portal venous blood via endoscopic ultrasound (EUS), and detect portal venous CTCs and analyze mRNA markers of exosomes by RNA-seq. The investigators aim to explore the potential molecular mechanisms in tumor microenvironment and mechanisms of drug resistance.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Aged from 18 to 80 years-old
- Suspected pancreatic masses and referred for EUS-FNA for pathology diagnosis
- Written informed consent
- Patients who have received adjuvant chemotherapy and other anti-tumor treatments
- Severe heart, lung, liver, kidney insufficiency, or severe bleeding disorders, severe coagulopathy or local/systemic infections, other critical illnesses
- Women who are planning to become pregnant or are pregnant or breast-feeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pancreatic cancer Endoscopic ultrasound-guided protal venous blood sampling Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology. Benign pancreatic diseases Endoscopic ultrasound-guided protal venous blood sampling Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology, e.g. PCLs.
- Primary Outcome Measures
Name Time Method The difference of the amount of circulating tumor cells acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases 08/01/2018-08/01/2020 In this study, the amount of the circulating tumor cells obtained from portal venous blood of suspected pancreatic masses patients will be determined by analyzing the expression of folate receptors. The investigators will compare the difference of the CTC amount between patients with pancreatic cancer and benign pancreatic diseases.
The difference of the exosomes acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases 08/01/2018-08/01/2020 Exosomes will be acquisited from portal venous blood of patients with suspected pancreatic masses. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between patients with pancreatic cancer and benign pancreatic diseases. (The mRNA markers will be selected from RNA-seq results.)
- Secondary Outcome Measures
Name Time Method The difference of the amount of circulating tumor cells between portal venous and peripheral blood 08/01/2018-08/01/2020 In this study, the amount of the circulating tumor cells obtained from portal venous blood and peripheral blood will be assessed for each patient respectively. The investigators will compare the difference of the CTC amount between portal venous blood and peripheral blood.
The difference of the exosomes between portal venous and peripheral blood 08/01/2018-08/01/2020 Exosomes will be acquisited from portal venous blood and peripheral blood for each patient. Then the total RNA will be extracted from the exosomes. The investigators will compare the expression of certain mRNA markers of the exosomes between portal venous and peripheral blood for each patient. (The mRNA markers will be selected from RNA-seq results.)
Trial Locations
- Locations (1)
Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China