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Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers

StatusRecruiting
PhaseNot specified
Started2020-06-16
View on ClinicalTrials.gov ↗
The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.

Amendment history 11 changes detected by DataLookout

2026-09-05
critical
Primary completion pushed: 2030-12-31 → 2034-11-11
2026-09-05
minor
Completion pushed: 2031-12-31 → 2034-11-11
2026-08-27
minor
Trial sites expanded: 424 → 429 locations
2026-05-28
notable
Phase changed: not applicable → not specified
2026-05-28
critical
Primary endpoint(s) modified
WasOccurrence of an "unfavorable" outcome
NowOccurrence of an "unfavorable" outcome (PRIOR TO ADDENDUM #5 08/13/2024), Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI)
2026-05-28
critical
Enrollment reduced: 4606 → 770 participants
2026-05-28
minor
Trial arms changed: 2 → 3
2026-05-28
minor
Primary completion moved earlier: 2037-06-03 → 2030-12-31
2026-05-28
minor
Completion moved earlier: 2037-06-03 → 2031-12-31
2026-05-16
minor
Trial sites expanded: 352 → 424 locations
2026-05-06
notable
Trial status changed: Active, Not Recruiting → Recruiting
Trial Details
NCT Number NCT04239573
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions Pancreatic Neoplasm
Enrollment 770 participants
Start Date 2020-06-16
Primary Completion 2034-11-11 (estimated)
Study Completion 2034-11-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-04