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Monitoring Methods for Pancreatic Cyst

N/A

Recruiting

Led By David S Weinberg

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Patient must be ≥ 50 years and ≤ 75 years of age.

Must not have

Patient must not have acute pancreatitis or a history of chronic pancreatitis.

Patient must not have a prior diagnosis of pancreatic malignancy of any type.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether more or less frequent monitoring of pancreatic cysts leads to better outcomes for patients.

Who is the study for?

This trial is for people aged 50-75 with pancreatic cysts larger than 1 cm, discovered in the last 6 months. It's not for those who are pregnant, have acute or chronic pancreatitis, a history of pancreatic cancer, specific low-risk lesions, family history of certain cancers, cyst features indicating surgery need, serious illnesses preventing surgery or current participation in other cyst monitoring.

What is being tested?

The study compares two ways to monitor pancreatic cysts: more frequent vs less frequent check-ups using CT scans, MRIs and endoscopic ultrasounds. The goal is to find out which method leads to better patient outcomes.

What are the potential side effects?

Potential side effects from the imaging tests include discomfort during procedures and exposure to radiation (CT scans). Endoscopic ultrasounds may cause sore throat or minor bleeding. Quality-of-life assessments and questionnaires carry no physical risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a scan showing a pancreatic cyst larger than 1 cm within the last 6 months.

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I am between 50 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have, nor have I ever had, pancreatitis.

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I have never been diagnosed with pancreatic cancer.

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I have never had surgery to remove part of my pancreas.

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My pancreatic cyst does not require immediate surgery.

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I do not have benign pancreatic lesions like pseudocysts or serous cystic lesions only.

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I do not have a family history of pancreatic cancer in my immediate family.

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I don't have any health conditions that would prevent surgery on a pancreatic cyst.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of an "unfavorable" outcome

Secondary study objectives

Biomarker analysis from collected samples to compare the predictive performance of known and future biomarkers for dysplasia or cancer

Healthcare utilization of imaging, invasive testing, surgical, and other procedures using information collected from sites.

Major surgical morbidity

+7 more

Other study objectives

Predictive accuracy of radiomic markers for dysplasia and pancreatic cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (high intensity surveillance)Experimental Treatment5 Interventions

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.

Group II: Arm I (low intensity surveillance)Experimental Treatment5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Endoscopic Ultrasound

2010

Completed Phase 2

~350