Clinical trial NCT03821909: Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS
Official title: Acquisition of Portal Venous Circulating Tumor Cells and Exosomes From Patients With Pancreatic Cancer by Endoscopic Ultrasound: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Portal venous blood
Circulating tumor cells
Exosome
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected to have pancreatic masses who are going to receive EUS-FNA operations for diagnostic purposes.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The difference of the amount of circulating tumor cells acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases
timeFrame: 08/01/2018-08/01/2020
measure: The difference of the exosomes acquisited from portal venous blood between patients with pancreatic cancer and benign pancreatic diseases
timeFrame: 08/01/2018-08/01/2020
Secondary outcomes:
measure: The difference of the amount of circulating tumor cells between portal venous and peripheral blood
timeFrame: 08/01/2018-08/01/2020
measure: The difference of the exosomes between portal venous and peripheral blood
timeFrame: 08/01/2018-08/01/2020
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Ying Lv, PhD
role: PRINCIPAL_INVESTIGATOR
References: