Genomic Profiling of Pancreatic Cystic Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

NA (No intervention): NA (No intervention)

Study summary

This study aims to find out whether quantitative and qualitative analysis, including genetic mutation analysis, of samples obtained from patients with pancreatic cysts is associated with the risk of malignancy, and helpful in the differential diagnosis of mucinous and serous cysts. The study design is a single-arm prospective cohort observational study. Using blood, pancreatic cyst fluid, and pancreatic cyst tissue, genetic mutation analysis and measurement of various biomarkers are performed, and the relationship between these and malignancy or whether they are helpful in distinguishing mucinous and serous cysts is analyzed. The primary outcome is genetic variants of pancreatic cysts associated with malignancy. The secondary outcomes are factors including genetic variants that differentiate mucinous from serous cysts.

Eligibility

Primary outcome measure(s)

• Genetic variants of pancreatic cysts associated with malignancy assessed by next-generation sequencing — Through study completion, an average of 3 years
  Genetic variants showing significant differences between pancreatic cysts with high-grade dysplasia or invasive cancer and the remaining pancreatic cysts, assessed through next-generation sequencing

Trial sites (2)

More Samsung Medical Center trials in South Korea