Comparing Two Methods to Follow Patients With Pancreatic Cysts

Not Applicable

Active, not recruiting

• Conditions: Pancreatic Carcinoma

• Registration Number: NCT04239573
• Lead Sponsor: ECOG-ACRIN Cancer Research Group

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 Timeline

• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-21
• Study First Posted: 2020-01-27
• Study Start: 2020-06-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-08
• Primary Completion: 2037-06-03
• Study Completion: 2037-06-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4606

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of an "unfavorable" outcome	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

Name	Time	Method
Rates of non-adherence	Up to 5 years	Will compare rates of non-adherence by arm assignment.
Major surgical morbidity	Up to 5 years	Rates of major surgical morbidity and/or mortality will be estimated and compared across arms.
Surgical and all-cause mortality	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.
Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites.	Up to 5 years	Will compare between two arms.
Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer	Up to 5 years	Will evaluate and compare the predictive performance of known and future biomarkers for dysplasia or cancer.
Patient reports of quality of life	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	Up to 5 years	Will be assessed by Patient Reported Outcomes Measurement Information System-Anxiety short form. Will compare between arms.
Pancreatic cancer incidence	Up to 5 years	Pancreatic-cancer incidence and pancreatic cancer specific mortality will be estimated and compared between the arms using log rank tests.
Patient (out-of-pocket and other indirect) costs collected from patient surveys	Up to 5 years	Will compare between two arms.
Patient report of financial distress collected through patient surveys	Up to 5 years	Will compare between arms.

Trial Locations

Locations (352)

University of Alabama at Birmingham Cancer Center; 🇺🇸 Birmingham, Alabama, United States

University of South Alabama Mitchell Cancer Institute; 🇺🇸 Mobile, Alabama, United States

Anchorage Associates in Radiation Medicine; 🇺🇸 Anchorage, Alaska, United States

Anchorage Radiation Therapy Center; 🇺🇸 Anchorage, Alaska, United States

Alaska Breast Care and Surgery LLC; 🇺🇸 Anchorage, Alaska, United States

Alaska Oncology and Hematology LLC; 🇺🇸 Anchorage, Alaska, United States

Alaska Women's Cancer Care; 🇺🇸 Anchorage, Alaska, United States

Anchorage Oncology Centre; 🇺🇸 Anchorage, Alaska, United States

Katmai Oncology Group; 🇺🇸 Anchorage, Alaska, United States

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

Scroll for more (342 remaining)