Genomic Profiling of Pancreatic Cystic Tumors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cyst
• Intervention / Treatment: Other: NA (No intervention)

Detailed Description

Pancreatic cysts, especially mucinous cysts, are precancerous lesions that can cause pancreatic cancer, and follow-up surveillance is important. However, there is a lack of clear medical evidence for the proper method and timing of follow-up, so the current follow-up strategies rely heavily on the opinions of experts. Although mucinous pancreatic cyst is known as a precancerous lesion, the incidence of cancer is about 1-5%. Therefore, if the risk of malignant disease can be more accurately predicted in patients with pancreatic cysts, patients with a high risk of malignant disease can be more intensively monitored and improved survival rates can be expected through early detection of pancreatic cancer. In addition, unnecessary medical resource consumption can be reduced by increasing the follow-up interval of pancreatic cyst patients with low risk of malignancy or not following them at all. To this end, in addition to imaging characteristics of pancreatic cysts, which are currently suggested as risk factors for malignancy in most guidelines for pancreatic cysts, differential diagnosis of pancreatic cysts based on new biomarkers such as genetic mutations and malignant risk assessment are necessary. Therefore, in this study, the investigators comprehensively analyze the blood, pancreatic cyst fluid, and pancreatic cyst tissue of patients with pancreatic cysts to explore biomarkers including genetic mutations that are helpful in the differential diagnosis of pancreatic cyst and the diagnosis of malignant tumors.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Young Hoon Choi, MD, PhD; Phone Number: 82-2-2258-6020; Email: crzyzs@naver.com
• Study Contact Backup: Name: Joo Kyung Park, MD, PhD; Phone Number: 82-2-3410-0200; Email: mdsophie@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
    • Contact: Joo Kyung Park, MD; Phone Number: 82-2-3410-3409; Email: mdsophie@gmail.com
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital
    • Contact: Young Hoon Choi, MD, PhD; Phone Number: 82-2-2258-6020; Email: crzyzs@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection

Description

Inclusion Criteria:

• Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection
• Patients who gave written informed consent

Exclusion Criteria:

• Anyone who has not signed a written consent form.
• Patients deemed unsuitable for research (severe infection, drug abuse, severe mental illness, etc.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2030

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: December 23, 2023
• First Posted (Estimated): January 8, 2024

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst
• Other Study ID Numbers: 2022-10-056; KC22TISI0829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No