Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS

Study Overview
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Brief Summary
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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
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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.

Official Title
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Acquisition of Portal Venous Circulating Tumor Cells and Exosomes From Patients With Pancreatic Cancer by Endoscopic Ultrasound: a Prospective Study

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Endoscopic ultrasound-guided protal venous blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from 18 to 80 years-old Suspected pancreatic masses and referred for EUS-FNA for pathology diagnosis Written informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pancreatic cancer<br>Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology. | Procedure: Endoscopic ultrasound-guided protal venous blood sampling<br>* We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.<br>|
| Benign pancreatic diseases<br>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. | Procedure: Endoscopic ultrasound-guided protal venous blood sampling<br>* We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of the amount of circulating tumor cells acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases | 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. | 08/01/2018-08/01/2020 | 
| The difference of the exosomes acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases | 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.) | 08/01/2018-08/01/2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference of the amount of circulating tumor cells between portal venous and peripheral blood | 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. | 08/01/2018-08/01/2020 | 
| The difference of the exosomes between portal venous and peripheral blood | 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.) | 08/01/2018-08/01/2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Portal venous blood, Circulating tumor cells, Exosome