NCT03821909

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

January 6, 2019

Last Update Submit

January 29, 2019

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerPortal venous bloodCirculating tumor cellsExosome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The difference of the amount of circulating tumor cells between portal venous and peripheral blood

    08/01/2018-08/01/2020

  • The difference of the exosomes between portal venous and peripheral blood

    08/01/2018-08/01/2020

Study Arms (2)

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

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

Interventions

Endoscopic ultrasound-guided protal venous blood samplingPROCEDURE

We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.

Benign pancreatic diseasesPancreatic cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Aged from 18 to 80 years-old
  • Suspected pancreatic masses and referred for EUS-FNA for pathology diagnosis
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Drum Tower Hospital the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

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.

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ying Lv, PhD

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu Zhang, PhD

CONTACT

13770728926zhangshu19900513@126.com

Ying Lv, PhD

CONTACT

13770755008lying1999@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 6, 2019

First Posted

January 30, 2019

Study Start

August 1, 2018

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

CN(1)