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

January 29, 2019 updated by: Ying Lv

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
        • Contact:
          • Guangshu Han, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suspected to have pancreatic masses who are going to receive EUS-FNA operations for diagnostic purposes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pancreatic cancer
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
We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.
Benign pancreatic diseases
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
We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.

What is the study measuring?

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
Time Frame: 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.
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
Time Frame: 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.)
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
Time Frame: 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.
08/01/2018-08/01/2020
The difference of the exosomes between portal venous and peripheral blood
Time Frame: 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.)
08/01/2018-08/01/2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ying Lv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 26, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPCE-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Endoscopic ultrasound-guided protal venous blood sampling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe