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Sponge Capsule Diagnosis for Esophageal Cancer

N/A
Recruiting
Led By Prasad G. Iyer, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have three or more risk factors for Barrett's Esophagus.
Male and female ages 50-85
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will test a newdevice to see if it can accurately detect Barrett's Esophagus and dysplasia/adenocarcinoma in people with or without GERD.

Who is the study for?
This trial is for men and women aged 50-85 who are primary care patients at Mayo Clinic Rochester or its Health Systems. It's specifically for those with three or more risk factors for Barrett's Esophagus, which often includes chronic acid reflux.Check my eligibility
What is being tested?
The study is testing a sponge capsule device to see if it can accurately detect Barrett's Esophagus and any early signs of esophageal cancer in people, particularly among those with long-term gastroesophageal reflux disease.See study design
What are the potential side effects?
Potential side effects from the sponge capsule procedure may include discomfort during swallowing, gagging, throat irritation, or minor bleeding. However, these are typically mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have three or more risk factors for Barrett's Esophagus.
Select...
I am between 50 and 85 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Aim 1 - Screening Population
Aim 2 - Case/Control Population BE Detection
Aim 3 - Dysplasia Detection Sensitivity and Specificity
Secondary outcome measures
Aim 1 - Screening Population Predictive Value
Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
Aim 2 - Case/Control Population Sensitivity and Specificity
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Upper endoscopy - No Barrett's EsophagusExperimental Treatment1 Intervention
Those that have no known Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Group II: Upper endoscopy - Barrett's EsophagusExperimental Treatment1 Intervention
Those that have a diagnosis of Barrett's Esophagus and are scheduled for an upper endoscopy will be approached and if agreeable undergo sponge capsule procedure as well as endoscopic biopsies and brushings of the esophagus.
Group III: Screening PopulationExperimental Treatment1 Intervention
Those that have gastroesophageal reflux or other risk factors for Barrett's Esophagus will be contacted and if agreeable undergo sponge capsule procedure and fill out questionnaires.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,765,790 Total Patients Enrolled
Prasad G. Iyer, M.D.Principal Investigator - Mayo Clinic
Mayo Clinic
1 Previous Clinical Trials
180 Total Patients Enrolled
Prasad G Iyer, MDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
730 Total Patients Enrolled

Media Library

Upper endoscopy - No Barrett's Esophagus Clinical Trial Eligibility Overview. Trial Name: NCT03961945 — N/A
Esophageal Cancer Research Study Groups: Upper endoscopy - No Barrett's Esophagus, Upper endoscopy - Barrett's Esophagus, Screening Population
Esophageal Cancer Clinical Trial 2023: Upper endoscopy - No Barrett's Esophagus Highlights & Side Effects. Trial Name: NCT03961945 — N/A
Upper endoscopy - No Barrett's Esophagus 2023 Treatment Timeline for Medical Study. Trial Name: NCT03961945 — N/A

Frequently Asked Questions

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

How many individuals have signed up to participate in this trial?

"To properly evaluate the efficacy of this clinical trial, 1350 patients must meet certain prerequisite requirements and take part in the studies. These tests are taking place at a range of locations such as Mayo Clinic Jacksonville situated in Jacksonville, Florida and Mayo Clinic Health Systems - Austin located in Austin, Minnesota."

Answered by AI

Are individuals younger than 70 years old adequate candidates for this trial?

"Per the parameters of this research, individuals aged 18 and above but under 90 are eligible to take part."

Answered by AI

Are there any vacancies remaining for this research trial?

"Affirmative, the information on clinicaltrials.gov indicates that this medical trial is currently in its recruitment phase. The study was initially published on July 1st 2021 and has since been amended as of October 10th 2022. 1350 individuals from 7 different research locations need to be enrolled for the trial's completion."

Answered by AI

Are there any participating locations in this urban area conducting the clinical trial?

"This trial is available at 7 different sites, including Mayo Clinic Jacksonville in Florida,Mayo Clinic Health Systems - Austin and the Mayo Clinic Arizona located in Scottsdale. Additionally, there are 4 more centres offering this medication."

Answered by AI

What are the fundamental aims of this exploration?

"During a 5 year period, the primary purpose of this trial is to observe Aim 1 - Screening Population. Other secondary objectives include assessing the predictive value between those with and without chronic GERD (Aim 1 - Screening Population Predictive Value), determining diagnostic uncertainty bias in criterion standards (Aim 3 - Dysplasia Detection Rate of Missed Dysplasia) , as well as validating sensitivity/specificity cut offs for BE prediction algorithms on independent patient cohorts (Aim 2 - Case/Control Population Sensitivity and Specificity)."

Answered by AI

Are there certain demographics that would benefit most from participating in this clinical research?

"This experiment is recruiting roughly 1350 participants, who must have a diagnosis of Barrett Esophagus and be aged between 18-90."

Answered by AI

Who else is applying?

What site did they apply to?
Mayo Clinic Arizona
Baylor Scott & White Research Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Prasad G. Iyer 2021. "Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03961945.
All > Esophagus Cancer
~500 spots leftby Jan 2026
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