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Construction of a Novel Multidimensional Target Synchronous Detection Method Based on DLD Chip-Microsphere Size Coding and Its Application in Early Diagnosis of Pancreatic Cancer

Construction of a Novel Multidimensional Target Synchronous Detection Method Based on DLD Chip-Microsphere Size Coding and Its Application in Early Diagnosis of Pancreatic Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111435
Enrollment
Unknown
Registered
2025-10-31
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer(PC)

Interventions

Gold Standard:The clinical diagnosis result (with pathological diagnosis as the gold standard for pancreatic cancer
clinical diagnosis and physical examination results for benign diseases and healthy controls).
Index test:A multi-dimensional target synchronous detection method based on DLD chip–PSµm size encoding (for detecting GPC1+Exos, miR-21, and CA19-9).

Sponsors

Southern Medical University Southern Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.PC Group: Voluntarily signed the informed consent form; Age >= 18 years; Diagnosed with pancreatic cancer (PC) by clinical endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), or postoperative pathological biopsy; Available residual blood samples from routine clinical laboratory tests completed before undergoing surgery, radiotherapy, or chemotherapy. 2.Patients with Benign Pancreatic/Biliary Diseases: Voluntarily signed the informed consent form; Age >= 18 years; Diagnosed with benign pancreatic or biliary diseases (such as chronic pancreatitis, gallstones, cholecystitis, choledocholithiasis, etc.) by clinical imaging examinations (e.g., CT, MRI, ultrasound) and laboratory tests, with no evidence of malignant tumor; Available residual blood samples from routine clinical laboratory tests completed before routine diagnosis and treatment. 3.Healthy Subjects: Voluntarily signed the informed consent form; Age >= 18 years; No diagnosed disease; Available residual blood sample from routine clinical laboratory tests completed during health check-ups.

Exclusion criteria

Exclusion criteria: 1.PC Group: Concomitant with other malignant tumors; Having undergone surgery, radiotherapy, or chemotherapy; Complicated with severe biliary obstruction or biliary system infection; Suffering from other chronic diseases; Incomplete serum marker testing; Judged by the investigator as unsuitable for participation in this study. 2.Patients with Benign Pancreatic/Biliary Diseases: Having received routine diagnosis and treatment; Suffering from malignant tumor; Complicated with severe biliary obstruction or biliary system infection; Suffering from other chronic diseases; Incomplete serum marker testing; Judged by the investigator as unsuitable for participation in this study. 3.Healthy Subjects: Incomplete serum marker testing; Suffering from chronic disease; Judged by the investigator as unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;Accuracy;

Countries

China

Contacts

Public ContactZhang Yuqin

Southern Medical University Southern Hospital

7913969631@qq.com+86 20 6164 2136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026