Tumor Exosome Liquid Biopsy Strategy to Diagnose Pancreatic Cancer

Pancreatic Clinical Trial

Official title:

Study on the Application of Tumor Exosome Liquid Biopsy in the Early Diagnosis of Pancreatic Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06108531
• Other study ID #: IIT-2023-0118
• Status: Enrolling by invitation
• Start date: November 1, 2023
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study of patients diagnosed with pancreatic cancer by pathology, with a control group of patients with pathology suggestive of benign pancreatic lesions and normal subjects, and the diagnostic ability of exosomes to identify patients with pancreatic cancer was assessed through the detection of exosomes in the peripheral blood.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Diagnosis of pancreatic cancer confirmed by imaging (case) Diagnosis of chronic pancreatitis confirmed by imaging (hospital control)

Exclusion Criteria:

The pathology diagnosis and imaging does not matched Patients with other malignant tumors Patients with other severe systemic diseases

Related Conditions & MeSH terms

• Pancreatic

Locations

Country	Name	City	State
China	Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of proteins in tumor exosomes from patients with pancreatic cancer	We will select specific protein A from circulating exosomes of pancreatic cancer patients for further analysis.	Up to 2 years from start of study
Primary	The expression of protein A in the circulating exosomes from patients	By detecting the expression of protein A in circulating exosomes of patients. the ROC curve of A+ circulating exosomes will be compared to clinical standard tumor biomarkers (e.g., CA199) in pancreatic cancer patients.	Up to 2 years from start of study