Genomic Profiling of Pancreatic Cystic Tumors

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection

Patients who gave written informed consent

Disqualifiers

Anyone who has not signed a written consent form.

Patients deemed unsuitable for research (severe infection, drug abuse, severe mental illness, etc.)

Trial population

Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NA (No intervention)

    Other intervention

    NA (No intervention)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Genetic variants of pancreatic cysts associated with malignancy assessed by next-generation sequencing

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

Time frame
Through study completion, an average of 3 years

Secondary outcomes

1

Genetic variants that differentiate mucinous from serous cysts assessed by next-generation sequencing

Genetic variants indicating significant differences between mucinous and serous cysts, as evaluated through next-generation sequencing

Time frame
Through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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