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Comparing Two Methods to Follow Patients With Pancreatic Cysts

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ClinicalTrials.gov Identifier: NCT04239573
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Tracking Information
First Submitted Date  ICMJE January 16, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date May 21, 2020
Actual Study Start Date  ICMJE January 16, 2020
Estimated Primary Completion Date December 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
Occurrence of an "unfavorable" outcome [ Time Frame: Up to 5 years ]
Defined as a composite of: (1) any pancreatic cancer without surgery; (2) unresectable pancreatic cancer or cancer > T1a, N0 at surgery, and (3) benign disease at surgery will be approached from the intent-to-treat perspective. Time to the first occurrence of the primary endpoint will measured from randomization. Survival analysis methods will be used to estimate and compare distributions of time to an unfavorable event between the study arms. In particular Kaplan-Meier estimates will be developed for each arm and a log rank test will be used to compare the two arms.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2020)
  • Surgical and all-cause mortality [ Time Frame: Up to 5 years ]
    Rates of major surgical morbidity and/or mortality will be estimated and compared across arms. All-cause mortality will be estimated and compared between the arms using log rank tests.
  • Major surgical morbidity [ Time Frame: Up to 5 years ]
    Rates of major surgical morbidity and/or mortality will be estimated and compared across arms.
  • Pancreatic cancer incidence [ Time Frame: Up to 5 years ]
    Pancreatic-cancer incidence and pancreatic cancer specific mortality will be estimated and compared between the arms using log rank tests.
  • Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites. [ Time Frame: Up to 5 years ]
    Will compare between two arms.
  • Patient (out-of-pocket and other indirect) costs collected from patient surveys [ Time Frame: Up to 5 years ]
    Will compare between two arms.
  • Patient reports of quality of life [ Time Frame: Up to 5 years ]
    Will be assessed by Patient Reported Outcomes Measurement Information System10. Will compare between arms. Longitudinal regression modelling will be completed to account for the repeated assessments over time.
  • Patient reports of situational anxiety [ Time Frame: Up to 5 years ]
    Will be assessed by Patient Reported Outcomes Measurement Information System-Anxiety short form. Will compare between arms.
  • Patient report of financial distress collected through patient surveys [ Time Frame: Up to 5 years ]
    Will compare between arms.
  • Rates of non-adherence [ Time Frame: Up to 5 years ]
    Will compare rates of non-adherence by arm assignment.
  • Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer [ Time Frame: Up to 5 years ]
    Will evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 21, 2020)
Predictive accuracy of radiomic markers for dysplasia and pancreatic cancer [ Time Frame: Up to 5 years ]
Will evaluate and compare the predictive accuracy of known and future radiomic markers for dysplasia and pancreatic cancer.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparing Two Methods to Follow Patients With Pancreatic Cysts
Official Title  ICMJE Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
Brief 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.
Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

V. 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:

I. 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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Pancreatic Carcinoma
Intervention  ICMJE
  • Procedure: Computed Tomography
    Undergo CT
    Other Names:
    • CAT
    • CAT scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT scan
    • tomography
  • Procedure: Endoscopic Ultrasound
    Undergo EUS
    Other Names:
    • endosonography
    • EUS
  • Procedure: Magnetic Resonance Imaging
    Undergo MRI
    Other Names:
    • Magnetic Resonance Imaging Scan
    • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
    • MR Imaging
    • MRI
    • MRI Scan
    • NMR Imaging
    • NMRI
    • nuclear magnetic resonance imaging
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Study Arms  ICMJE
  • Experimental: Arm I (low intensity surveillance)
    Patients undergo MRI or 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 EUS, repeat MRI or CT in 1 year. Patients with negative imaging repeat MRI or CT in 2 years.
    Interventions:
    • Procedure: Computed Tomography
    • Procedure: Endoscopic Ultrasound
    • Procedure: Magnetic Resonance Imaging
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
  • Experimental: Arm II (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.
    Interventions:
    • Procedure: Computed Tomography
    • Procedure: Endoscopic Ultrasound
    • Procedure: Magnetic Resonance Imaging
    • Other: Quality-of-Life Assessment
    • Other: Questionnaire Administration
Publications * Weinberg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2020)
4606
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2027
Estimated Primary Completion Date December 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Patient must not have acute pancreatitis or a history of chronic pancreatitis
  • Patient must have received a computed tomography (CT) or magnetic resonance imaging (MRI) within 3 months of registration that revealed a newly identified >= 1 cm pancreatic cyst
  • Women of childbearing potential must not be known to be pregnant
  • Patient must not have a prior diagnosis of pancreatic cyst or pancreatic malignancy of any type
  • Patient must not have a history of pancreatic resection
  • Patient must not have other asymptomatic pancreatic cystic lesion with zero/low malignancy potential (pancreatic pseudocyst, classic serous cystic lesion) on index CT or MRI
  • Patient must not have a family history of pancreatic adenocarcinoma in 1 or more first degree relatives
  • Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct > 10 mm, cyst causing obstructive jaundice)
  • Patient must not have a comorbid illness that precludes pancreatic cyst resection
  • Patient must not be participating in an already established surveillance program
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04239573
Other Study ID Numbers  ICMJE EA2185
NCI-2019-04790 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EA2185 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN-EA2185 ( Other Identifier: DCP )
EA2185 ( Other Identifier: CTEP )
UG1CA189828 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
Study Sponsor  ICMJE ECOG-ACRIN Cancer Research Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: David S Weinberg ECOG-ACRIN Cancer Research Group
PRS Account Eastern Cooperative Oncology Group
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP