Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer

NCT04536220 | Recruiting

• 1 other identifier: EMPVC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diagnoses Disease

Keywords

diagnosis and pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Status of survival

  To varify if the patients died becaused of malignant pancreatic cancer.

  through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

Endoscopic Ultrasound (EUS), Fine Needle Aspiration DIAGNOSTIC_TEST

Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations

pancreatic mass diagnosed benign; pancreatic mass diagnosed malignant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Specimen collected from pancreatic mass through EUS-FNA, blood collected from portal vein through EUS-FNA, as well as peripheral blood from the patients with pancreatic mass suspicious of malignant pancreatic tumor.

MeSH Terms

Conditions

Disease; Pancreatic Neoplasms

Interventions

Endosonography; Biopsy, Fine-Needle

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Kaixuan Wang, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Kong, MD

CONTACT

13564644397; xiangyukong185@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prefessor of Department of Gastroenterology

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 2, 2020
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)