COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821909
Recruitment Status : Unknown
Verified January 2019 by Ying Lv, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Recruitment status was:  Recruiting
First Posted : January 30, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ying Lv, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Pancreatic Cancer Procedure: Endoscopic ultrasound-guided protal venous blood sampling

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acquisition of Portal Venous Circulating Tumor Cells and Exosomes From Patients With Pancreatic Cancer by Endoscopic Ultrasound: a Prospective Study
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.)


Secondary Outcome Measures :
  1. 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.

  2. 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.)


Biospecimen Retention:   Samples With DNA
We will obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses, detect circulating tumor cells and analyze the mRNA markers of the exosomes by RNA-seq.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients suspected to have pancreatic masses who are going to receive EUS-FNA operations for diagnostic purposes.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821909


Contacts
Layout table for location contacts
Contact: Shu Zhang, PhD 13770728926 ext +86 zhangshu19900513@126.com
Contact: Ying Lv, PhD 13770755008 ext +86 lying1999@126.com

Locations
Layout table for location information
China, Jiangsu
Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Guangshu Han, PhD         
Sponsors and Collaborators
Ying Lv
Investigators
Layout table for investigator information
Principal Investigator: Ying Lv, PhD The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ying Lv, Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03821909    
Other Study ID Numbers: EPCE-1
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ying Lv, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
Pancreatic cancer
Portal venous blood
Circulating tumor cells
Exosome
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases