Summary

Eligibility
for people ages 50-75 (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Rebekah R. White (ucsd)Timothy R. Donahue (ucla)Kimberly Kirkwood (ucsf)
Headshot of Rebekah R. White
Rebekah R. White
Headshot of Kimberly Kirkwood
Kimberly Kirkwood

Description

Summary

The purpose of this study is to compare the two approaches for monitoring pancreatic cysts. The study doctors want to compare more frequent monitoring vs less frequent monitoring in order to learn which monitoring method leads to better outcome for patients with pancreatic cysts.

Official Title

Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs

Details

PRIMARY OBJECTIVES:

  1. To compare the rates of unfavorable clinical outcomes in the two arms.

SECONDARY OBJECTIVES:

  1. To compare rates of major surgical morbidity and/or mortality between arms. II. To compare pancreatic cancer incidence and all-cause mortality across arms. III. Compare institutional (direct) costs. IV. Compare healthcare utilization of imaging, invasive testing, surgical, and other procedures across the two surveillance arms.
  2. Compare patient (out-of-pocket and other indirect) costs. VI. Describe diagnostic test and treatment pathways by arm. VII. Compare patient reports of quality of life (QOL), situational anxiety. VIII. Compare patient report of financial distress. IX. Compare rates of non-adherence by arm assignment. X. To evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.

EXPLORATORY OBJECTIVE:

  1. To evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A (LOW INTENSITY SURVEILLANCE): Patients undergo magnetic resonance imaging (MRI) or computed tomography (CT) at the beginning of the trial and 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 endoscopic ultrasound (EUS), repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years.

ARM B (HIGH INTENSITY SURVEILLANCE): Patients undergo MRI or CT. Patients with 1-2 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 2-3 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 EUS within 6 months, and if EUS is negative, patients undergo alternate MRI or CT with EUS every 3-6 months.

After completion of imaging procedures, patients are followed up for 5 years from the date of registration .

Keywords

Pancreatic Carcinoma, Pancreatic Neoplasms, Pancreatic Cyst, Computed Tomography, Endoscopic Ultrasound, Magnetic Resonance Imaging, Quality-of-Life Assessment

Eligibility

For people ages 50-75

  • 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 randomization 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 pancreatic cyst resection.
  • Patient must not be participating in any form of pancreatic cyst surveillance.

Locations

  • UC San Diego Health System - Encinitas currently not accepting new patients, but might later
    Encinitas California 92024 United States
  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UCLA / Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States
  • UC San Diego Medical Center - Hillcrest currently not accepting new patients, but might later
    San Diego California 92103 United States
  • UCSF Medical Center-Mount Zion accepting new patients
    San Francisco California 94115 United States
  • UCSF Medical Center-Parnassus accepting new patients
    San Francisco California 94143 United States
  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center accepting new patients
    Burbank California 91505 United States

Lead Scientists at University of California Health

  • Rebekah R. White (ucsd)
    Professor, Surgery, Vc-health Sciences-schools. Authored (or co-authored) 40 research publications
  • Timothy R. Donahue (ucla)
    Dr. Timothy Donahue holds the Garry Shandling Chair in Pancreatic Surgery. He is also the Director of the UCLA Agi Hirshberg Center for Pancreatic Diseases.
  • Kimberly Kirkwood (ucsf)
    Professor, Surgery, School of Medicine. Authored (or co-authored) 62 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ECOG-ACRIN Cancer Research Group
ID
NCT04239573
Study Type
Interventional
Participants
Expecting 4606 study participants
Last Updated