Health TrialsbyHealthPanel

Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma

ConditionsBarrett EsophagusEsophageal Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMayo Clinic

About this trial

This study will evaluate if the sponge capsule device can accurately detect the presence of Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection, in a screening population, with and without chronic gastroesophageal reflux disease.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female ages 50-85

Patients who have three or more risk factors for Barrett's Esophagus.

Diagnosis

Use of one of the following drugs >= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine

Disqualifiers

esophageal adenocarcinoma/cancer

esophageal squamous carcinoma

endoscopic ablation for Barrett's esophagus

esophageal squamous dysplasia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sponge Capsule

    Device

    Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Treatment groups

1,550 Participants
are divided into 3 treatment groups
Group A: Screening PopulationOther 1 intervention
Group B: Upper endoscopy - Barrett's EsophagusOther 1 intervention
Group C: Upper endoscopy - No Barrett's EsophagusOther 1 intervention

Trial outcomes

Primary outcomes

1

Aim 1 - Screening Population

To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.

Time frame
5 years
2

Aim 2 - Case/Control Population BE Detection

Compare the sensitivity and specificity of a predetermined BE prediction algorithm for those with and without GERD and assess the influence of other covariates (age, sex, ever smoking, ethnicity and BMI) on this algorithm.

Time frame
5 years
3

Aim 3 - Dysplasia Detection Sensitivity and Specificity

Measure the sensitivity and specificity of a predetermined MDM panel assayed on SOS specimens from BE patients identified in Aims 1 and 2, for the detection of HGD /EAC, using surveillance histology as the criterion standard.

Time frame
5 years

Secondary outcomes

1

Aim 1 - Screening Population Predictive Value

Compare positive predictive value and negative predictive value of the sponge capsule Barrett's Esophagus test between those with and without chronic GERD.

Time frame
5 years
2

Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure

Safety and tolerability of the sponge capsule device in a screening population as measured by a Tolerability Questionnaire with sponge capsule procedure. Participants will rate their tolerability by rating questions using a scale of 0-10 (0 is none and 10 is severe or 0 is good and 10 is not good).

Time frame
5 years
3

Aim 2 - Case/Control Population Sensitivity and Specificity

Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort

Time frame
5 years
4

Aim 3 - Dysplasia Detection Rate of Missed Dysplasia

Measure diagnostic uncertainty bias in the criterion standard, specifically, the rate of dysplasia missed by surveillance histology

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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