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Enrolling by invitationNCT06108531Updated Oct 31, 2023

Tumor Exosome Liquid Biopsy Strategy to Diagnose Pancreatic Cancer

An observational study in Pancreatic, sponsored by Shanghai Jiao Tong University School of Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-31.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic
03

In context

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 years from start of study

  2. 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.

    Time frame: Up to 2 years from start of study

07

Study locations

1 site
  • Xinhua Hospital, Affiliated to Shanghai Jiao Tong University, School of Medicine
    Shanghai, Shanghai 20092, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06108531
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Yingbin Liu, MD, PhD, FACS (vice-president,Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Oct 31, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Aug 1, 2025 (estimated)
Completion
Aug 1, 2026 (estimated)
Last update
Oct 31, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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