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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 : December 2, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Carcinoma Procedure: Computed Tomography Procedure: Endoscopic Ultrasound Procedure: Magnetic Resonance Imaging Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
Actual Study Start Date : January 16, 2020
Estimated Primary Completion Date : March 15, 2031
Estimated Study Completion Date : March 15, 2033

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Major surgical morbidity [ Time Frame: Up to 5 years ]
    Rates of major surgical morbidity and/or mortality will be estimated and compared across arms.

  3. 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.

  4. 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.

  5. Patient (out-of-pocket and other indirect) costs collected from patient surveys [ Time Frame: Up to 5 years ]
    Will compare between two arms.

  6. 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.

  7. 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.

  8. Patient report of financial distress collected through patient surveys [ Time Frame: Up to 5 years ]
    Will compare between arms.

  9. Rates of non-adherence [ Time Frame: Up to 5 years ]
    Will compare rates of non-adherence by arm assignment.

  10. 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.


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239573


Locations
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Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: David S Weinberg ECOG-ACRIN Cancer Research Group
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT04239573    
Other Study ID Numbers: 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 )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Cyst
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cysts