Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536220
• Other study ID #: EMPVC
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: July 30, 2026

Study information

• Verified date: March 2024
• Source: Changhai Hospital
• Contact: Xiangyu Kong, MD
• Phone: 13564644397
• Email: xiangyukong185[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2026
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Endoscopic Ultrasound (EUS), Fine Needle Aspiration
Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Status of survival	To varify if the patients died becaused of malignant pancreatic cancer.	through study completion, an average of 1 year