Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer

March 28, 2024 updated by: Zhaoshen Li, Changhai Hospital

Establish a Diagnostic Model Based on Multiple Molecule Profiling and Certain Established Markers for Identification of Pancreatic Cancer

Explore new markers based on portal venous blood sampling to establish novel diagnostic models for identification of malignant pancreatic mass.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

EUS-FNA combined cytology detection is an important method for clinical diagnosis of squamous cell carcinoma. However, due to factors such as sampling method, smear making, staining technique, lower levels of the pathologists and other factors, its diagnostic sensitivity is still not very satisfactory. Poor diagnostic efficacy usually means another puncture, longer hospital stay, more medications and a higher incidence of adverse events. Missed diagnosis continuously directly delays the treatment time of the disease and seriously affects the patient's prognosis. Therefore, how to use new technologies to improve the differential diagnosis efficiency of benign and malignant pancreatic occupants is the key to improving the prognosis of diabetic cancer patients.

The portal vein blood comes from the venous tract, including the blood flowing from the plasma to the liver. By collecting blood samples from the patient's portal vein, clinicians can separate more information from the patient. Studies have shown that the portal vein blood can be collected by ultrasound endoscopic puncture. This method is less traumatic, convenient and safe, and more information about the retinal tissue can be obtained. It is an important way to improve the efficiency of patient diagnosis. This study intends to use ultrasound endoscopic puncture technology to obtain portal vein blood, and use big data and ctDNA, metabolomics, exosomes and other different omics methods to screen the potential value of volume-occupying benign and malignant differential diagnosis markers in portal vein blood. Peripheral blood will simultaneously be collected to evaluate the efficacy of these newly developed markers.

Study Type

Observational

Enrollment (Estimated)

300

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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433

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

N/A

Sampling Method

Non-Probability Sample

Study Population

All patients who meet the inclusion criteria, but not the exclusion criteria, will be included in current study. Pancreatic mass tissue samples, portal venous blood, and periferal blood will be collected for identification of potential markers for diagnosis of malignant pancreatic cancer.

Description

Inclusion Criteria:

  1. age 18-75 years,male or female
  2. diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
  3. lesion diameter larger than 1 cm
  4. signed informed consent letter

Exclusion Criteria:

  1. pregnant female
  2. Pancreatic cystic lesions
  3. Anticoagulant/antiplatelet therapy cannot be suspended
  4. unable or refuse to provide informed consent
  5. Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
  6. Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
  7. with history of mental disease
  8. other medical conditions that are not suitable for EUS-FNA

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pancreatic mass diagnosed benign
Through pathological examination, radiological examination and follow-up, these patients are finally diagnosed with benign pancreatic mass.
Diagnostic test: Endoscopic Ultrasound (EUS), Fine Needle Aspiration
Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations
pancreatic mass diagnosed malignant
Through pathological examination, radiological examination and follow-up, these patients are finally diagnosed with pancreaitic cancer.
Diagnostic test: Endoscopic Ultrasound (EUS), Fine Needle Aspiration
Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of survival
Time Frame: through study completion, an average of 1 year
To varify if the patients died becaused of malignant pancreatic cancer.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Kaixuan Wang, MD, Changhai Hospital

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)

January 1, 2024

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMPVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Within six months this study has been finished

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.

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