Tumor Exosome Liquid Biopsy Strategy to Diagnose Pancreatic Cancer

NCT06108531 | Enrolling By Invitation

• 1 other identifier: IIT-2023-0118
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

pancreatic patients

Cases will be the patients with newly-diagnosed pancreatic.

The controls

Controls will be selected from patients with pancreatitis from the same hospital as the case, matched by gender, race and age (1:1).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cases will be patients with newly diagnosed pancreatic cancer. Controls will be selected from patients with pancreatitis in the same hospital as the cases, matched by sex, race and age (1:1). A total of 400 patients with gallbladder cancer will be recruited.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 20092, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president，Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

CN (1)