Genomic Profiling of Pancreatic Cystic Tumors

Pancreatic Cyst Clinical Trial

Official title:

Genomic Profiling of Pancreatic Cystic Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195904
• Other study ID #: 2022-10-056; KC22TISI0829
• Status: Not yet recruiting
• Start date: January 15, 2024
• Est. completion date: May 15, 2030

Study information

• Verified date: December 2023
• Source: Samsung Medical Center
• Contact: Young Hoon Choi, MD, PhD
• Phone: 82-2-2258-6020
• Email: crzyzs[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: May 15, 2030
• Est. primary completion date: May 15, 2028
• Gender: All
• Age group: 19 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Pancreatic Cyst

Intervention

Other:
• NA (No intervention)
NA (No intervention)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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