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

NCT ID: NCT03821909

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer

Keywords

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Pancreatic cancer Portal venous blood Circulating tumor cells Exosome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatic cancer

Endoscopic ultrasound-guided protal venous blood sampling will be performed for each patient. And the diagnosis will be confirmed by tissue pathology.

Endoscopic ultrasound-guided protal venous blood sampling

Intervention Type PROCEDURE

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.

Endoscopic ultrasound-guided protal venous blood sampling

Intervention Type PROCEDURE

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

Interventions

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Endoscopic ultrasound-guided protal venous blood sampling

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ying Lv

OTHER

Sponsor Role lead

Responsible Party

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Ying Lv

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ying Lv, PhD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

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

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shu Zhang, PhD

Role: CONTACT

Phone: 13770728926

Email: [email protected]

Ying Lv, PhD

Role: CONTACT

Phone: 13770755008

Email: [email protected]

Facility Contacts

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Guangshu Han, PhD

Role: primary

Other Identifiers

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EPCE-1

Identifier Type: -

Identifier Source: org_study_id