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

Conditions

• Pancreatic Neoplasm

Eligibility Criteria

Sex

ALL

Age

50 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT
• Endoscopic Ultrasound — PROCEDURE
  Undergo EUS
• Endoscopic Ultrasound-Guided Fine-Needle Aspiration — PROCEDURE
  Undergo EUS-FNA
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Quality-of-Life Assessment — OTHER
  Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)
• Questionnaire Administration — OTHER
  Ancillary studies (PRIOR TO ADDENDUM #5 08/13/2024)
• Surgical Procedure — PROCEDURE
  Undergo surgery

Study Details

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.

Key Dates

Start date

Jun 16, 2020

Status verified

May 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2031

Study Design

Enrollment

770 participants (estimated)

Arms

• Arm: Arm A (low intensity surveillance)
  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)
• Arm: Arm B (high intensity surveillance)
  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)
• Arm: Observational
  Patients undergo MRI or CT as well as blood sample collection throughout the trial. Patients undergo EUS, FNA, biopsy and surgery as clinically indicated.

Primary Outcome Measure

Time-to-finding of a worrisome feature and/or high-risk stigmata on computed tomography (CT) or magnetic resonance imaging (MRI) [ Time Frame: Up to 5 years ]

Locations (408)

Find similar trials in Birmingham, AL

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