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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of an "unfavorable" outcome

Secondary outcome measures

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 outcome measures

Predictive accuracy of radiomic markers for dysplasia and pancreatic cancer

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

~2720

Endoscopic Ultrasound

2010

Completed Phase 2

~350

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

172,316 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,921,159 Total Patients Enrolled

David S WeinbergPrincipal InvestigatorECOG-ACRIN Cancer Research Group

2 Previous Clinical Trials

70 Total Patients Enrolled

Media Library

Computed Tomography Clinical Trial Eligibility Overview. Trial Name: NCT04239573 — N/A

Pancreatic Cancer Research Study Groups: Arm I (low intensity surveillance), Arm II (high intensity surveillance)

Pancreatic Cancer Clinical Trial 2023: Computed Tomography Highlights & Side Effects. Trial Name: NCT04239573 — N/A

Computed Tomography 2023 Treatment Timeline for Medical Study. Trial Name: NCT04239573 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively seeking volunteers?

"Affirmative. Based on the data hosted on clinicaltrials.gov, this research is presently recruiting patients who began being sought after January 16th 2020 and continued through December 1st 2022. This investigation seeks to involve 4606 participants across a hundred different sites."

Answered by AI

In what regions is this experiment being conducted?

"This trial has recruited 100 patients across various sites, including the Providence Cancer Institute Clackamas Clinic in Clackamas, Penn Medicine Princeton Health in Plainsboro, and UC San Diego Health System - Encinitas in Encinitas."

Answered by AI

What is the aggregate number of individuals involved in this clinical experiment?

"Affirmative. The clinicaltrials.gov website provides evidence that this study is actively recruiting volunteers, with the trial having gone live on January 16th 2020 and being updated as recently as December 1st 2022. 4606 individuals will be needed to fill out 100 different medical centres across the country."

Answered by AI