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

Pancreatic Cancer Clinical Trial

— CTCs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821909
• Other study ID #: EPCE-1
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: September 2020

Study information

• Verified date: January 2019
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Shu Zhang, PhD
• Phone: 13770728926
• Email: zhangshu19900513[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged from 18 to 80 years-old

2. Suspected pancreatic masses and referred for EUS-FNA for pathology diagnosis

3. Written informed consent

Exclusion Criteria:

1. Patients who have received adjuvant chemotherapy and other anti-tumor treatments

2. Severe heart, lung, liver, kidney insufficiency, or severe bleeding disorders, severe coagulopathy or local/systemic infections, other critical illnesses

3. Women who are planning to become pregnant or are pregnant or breast-feeding

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Endoscopic ultrasound-guided protal venous blood sampling
We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Ying Lv

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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