Clinical trial · Observational
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
NCT04239573CI-TRIAL-00126068recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Procedure | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| Endoscopic Ultrasound | Procedure | — | UNRESOLVED |
| Endoscopic Ultrasound-Guided Fine-Needle Aspiration | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Arm A (low intensity surveillance)
- description
- Patients undergo MRI, CT, or EUS at the beginning of the trial and MRI or CT again in 1 year. Following the first year, patients with no abnormalities repeat MRI or CT every 2 years. Patients with positive imaging features on MRI and CT at 1 or 2 years and with negative EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
- interventionNames
- Procedure: Biopsy Procedure
- Procedure: Biospecimen Collection
- Procedure: Computed Tomography
- Procedure: Endoscopic Ultrasound
- Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration
- Procedure: Magnetic Resonance Imaging
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- label
- Arm B (high intensity surveillance)
- description
- Patients undergo MRI, CT, or EUS at the beginning of the trial. Patients with \>= 1 and \< 2 cm cyst undergo MRI or CT every 6 months for 1 year, then every 12 months for 2 years, and then every 24 months thereafter. Patients with \>= 2 and \< 3 cm cyst undergo EUS within 6 months, and if EUS is negative, patients repeat MRI or CT in 1 year. If second EUS is negative, patients undergo alternate MRI or CT and EUS every 12 months. Patients with cyst \>= 3 cm undergo alternate MRI or CT with EUS every 3-6 months. Patients may also optionally undergo blood sample collection, biopsy and/or EUS-FNA on study. (CLOSED TO ACCRUAL 08/13/2024)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must be ≥ 50 years and ≤ 75 years of age * Patient must not have acute pancreatitis or a history of chronic pancreatitis * Patient must have received a CT, MRI, or EUS within 6 months prior to enrollment that revealed one or more ≥ 1 cm pancreatic cyst(s). * Patients of childbearing potential must not be known to be pregnant * Patient must not have a prior diagnosis of pancreatic malignancy of any type * Patient must not have a history of pancreatic resection * Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible * Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children) * Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥ 10mm, cyst causing obstructive jaundice) * Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection * Patient must not be in any form of pancreatic cyst surveillance for \> 1 year, defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest * PRIOR TO ADDENDUM #5 08/13/2024: Patient must be ≥ 50 years and ≤ 75 years of age * PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have acute pancreatitis or a history of chronic pancreatitis. * PRIOR TO ADDENDUM #5 08/13/2024: Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s). * PRIOR TO ADDENDUM #5 08/13/2024: Patients of childbearing potential must not be known to be pregnant. * PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a prior diagnosis of pancreatic malignancy of any type. * PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a history of pancreatic resection. * PRIOR TO ADDENDUM #5 08/13/2024: Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible. * PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children). * PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥10mm, cyst causing obstructive jaundice). * PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection.
References
Publications (1)
- DERIVEDWeinberg DS, Gatsonis C, Zeh HJ, Carlos RC, O'Dwyer PJ; EA2185 Team. Comparing the clinical impact of pancreatic cyst surveillance programs: A trial of the ECOG-ACRIN cancer research group (EA2185). Contemp Clin Trials. 2020 Oct;97:106144. doi: 10.1016/j.cct.2020.106144. Epub 2020 Sep 10. PMID 32920242