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.
Brief Title
Comparing Two Methods to Follow 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 .
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 .
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Pancreatic Carcinoma
Eligibility 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.
* 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.
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 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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
50 Years
NCT Id
NCT04239573
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EA2185
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs
Primary Outcomes
Outcome Description
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.
Outcome Measure
Occurrence of an "unfavorable" outcome
Outcome Time Frame
Up to 5 years
Secondary Ids
Secondary Id
NCI-2019-04790
Secondary Id
EA2185
Secondary Id
ECOG-ACRIN-EA2185
Secondary Id
EA2185
Secondary Id
UG1CA189828
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to 5 years
Outcome Measure
Surgical and all-cause mortality
Outcome Description
Rates of major surgical morbidity and/or mortality will be estimated and compared across arms.
Outcome Time Frame
Up to 5 years
Outcome Measure
Major surgical morbidity
Outcome Description
Pancreatic-cancer incidence and pancreatic cancer specific mortality will be estimated and compared between the arms using log rank tests.
Outcome Time Frame
Up to 5 years
Outcome Measure
Pancreatic cancer incidence
Outcome Description
Will compare between two arms.
Outcome Time Frame
Up to 5 years
Outcome Measure
Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites.
Outcome Description
Will compare between two arms.
Outcome Time Frame
Up to 5 years
Outcome Measure
Patient (out-of-pocket and other indirect) costs collected from patient surveys
Outcome Description
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.
Outcome Time Frame
Up to 5 years
Outcome Measure
Patient reports of quality of life
Outcome Description
Will be assessed by Patient Reported Outcomes Measurement Information System-Anxiety short form. Will compare between arms.
Outcome Time Frame
Up to 5 years
Outcome Measure
Patient reports of situational anxiety
Outcome Description
Will compare between arms.
Outcome Time Frame
Up to 5 years
Outcome Measure
Patient report of financial distress collected through patient surveys
Outcome Description
Will compare rates of non-adherence by arm assignment.
Outcome Time Frame
Up to 5 years
Outcome Measure
Rates of non-adherence
Outcome Description
Will evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.
Outcome Time Frame
Up to 5 years
Outcome Measure
Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
John McAuliffe
Investigator Email
jomcauli@montefiore.org
Investigator Department
Surgery
Investigator Sponsor Organization
External
Study Department
Surgery
Study Division
Cancer Related - Please Specify
Categories Mesh Debug
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Endocrine System Cancers --- ENDOCRINE SYSTEM DISEASES
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
MeSH Terms
PANCREATIC NEOPLASMS
DIGESTIVE SYSTEM NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
ENDOCRINE GLAND NEOPLASMS
DIGESTIVE SYSTEM DISEASES
PANCREATIC DISEASES
ENDOCRINE SYSTEM DISEASES
ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION
MAGNETIC RESONANCE SPECTROSCOPY
BIOPSY, FINE-NEEDLE
BIOPSY, NEEDLE
BIOPSY
CYTODIAGNOSIS
CYTOLOGICAL TECHNIQUES
CLINICAL LABORATORY TECHNIQUES
DIAGNOSTIC TECHNIQUES AND PROCEDURES
DIAGNOSIS
IMAGE-GUIDED BIOPSY
SPECIMEN HANDLING
ULTRASONOGRAPHY, INTERVENTIONAL
ULTRASONOGRAPHY
DIAGNOSTIC IMAGING
DIAGNOSTIC TECHNIQUES, SURGICAL
SURGICAL PROCEDURES, OPERATIVE
MINIMALLY INVASIVE SURGICAL PROCEDURES
INVESTIGATIVE TECHNIQUES
SPECTRUM ANALYSIS
CHEMISTRY TECHNIQUES, ANALYTICAL