Health TrialsbyHealthPanel

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

ConditionsBarrett EsophagusEsophageal Adenocarcinoma
Trial statusCompleted
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

1,526 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

This trial is not recruiting at the moment. You can still explore other options: