Genomic Profiling of Pancreatic Cystic Tumors
1 other identifier
observational
250
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedStudy Start
First participant enrolled
January 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2030
January 8, 2024
December 1, 2023
4.3 years
November 22, 2023
December 23, 2023
Conditions
Outcome Measures
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
Through study completion, an average of 3 years
Secondary Outcomes (1)
Genetic variants that differentiate mucinous from serous cysts assessed by next-generation sequencing
Through study completion, an average of 3 years
Interventions
NA (No intervention)
Eligibility Criteria
Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection
You may qualify if:
- Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection
- Patients who gave written informed consent
You may not qualify if:
- Anyone who has not signed a written consent form.
- Patients deemed unsuitable for research (severe infection, drug abuse, severe mental illness, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Samsung Medical Center
Seoul, 06351, South Korea
Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Biospecimen
Blood Pancreatic cyst fluid Pancreatic cyst tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 22, 2023
First Posted
January 8, 2024
Study Start
January 15, 2024
Primary Completion (Estimated)
May 15, 2028
Study Completion (Estimated)
May 15, 2030
Last Updated
January 8, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share