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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04592393
Other study ID # SNUH-2020-2950
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 28, 2020
Est. completion date December 31, 2027

Study information

Verified date August 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to establish a prospective cohort of developing pancreas cancer and surveillance MRI protocol. With the focused surveillance protocol, we perform surveillance for pancreas cancer for five years to estimate the risk of pancreas cancer and the clinical feasibility of the surveillance MRI.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 50 Years to 75 Years
Eligibility Inclusion Criteria: - On follow-up due to first degree-family history of PAC - Or on follow-up for BD-IPMN (>= 2 cm) or main-duct type IPMN (> 5 mm) - And signed informed consent Exclusion Criteria: - Contra-indication of performing MRI - Not satisfying the selection criteria. - Previously diagnosed with pancreatic malignancy - Pregnancy or planning pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Abbreviated PB MRI
Annual non-contrast PB MRI.
Genetic:
Gene mutation test
K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.
Diagnostic Test:
Conventional follow-up
Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Comparison of performance of abbreviated PB MRI comparison of the rates of pancreas cancer detection between abbreviated MRI and conventional follow-up methods (in available cases) 1 year after the last surveillance MRI.
Other Identification of super-high risk group of developing pancreas cancer Identification of any common radiologic features and gene mutation in participants in whom pancreas cancer develop during the study period. 1 year after the last surveillance MRI.
Primary Detection of pancreas cancer number of detected pancreas cancer (resectable & BRPC only) in surveillance MRI. 1 year after the last surveillance MRI.
Secondary Scan time of abbreviated PB MRI for surveillance table time, in-room time measurement for feasibility 1 month after the first surveillance MRI.
Secondary Estimation of pancreas cancer risk rate of developing pancreas cancer during the study period 1 year after the last surveillance MRI.
Secondary Detection of pancreas cancer number of detected pancreas cancer of all stages (resectable, BRPC, LAPC, metastatic) in surveillance MRI. 1 year after the last surveillance MRI.
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