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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03961945
• Collaborator: (none)
• Enrollment: 1,350
• Locations: 6
• Arms: 3
• Anticipated Duration (Months): 66.1
• Patients Per Site: 225
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Barrett Esophagus; Esophageal Adenocarcinoma	Device: Sponge Capsule	N/A

Detailed Description

The SOS device will be safely administered by a non-physician such as a nurse. Novel discriminant methylated DNA markers will be assayed on esophageal cytology specimens obtained from a sponge on a string (SOS) device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1350 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Jan 2, 2026
• Anticipated Study Completion Date: Jan 2, 2027

Arms and Interventions

Arm	Intervention/Treatment
Other: Screening Population 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.	Device: Sponge Capsule; Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.; Other Names: EsophaCap
Other: Upper endoscopy - Barrett's Esophagus 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.	Device: Sponge Capsule; Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.; Other Names: EsophaCap
Other: Upper endoscopy - No Barrett's Esophagus 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.	Device: Sponge Capsule; Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.; Other Names: EsophaCap

Outcome Measures

Primary Outcome Measures

1. Aim 1 - Screening Population [5 years]

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

2. Aim 2 - Case/Control Population BE Detection [5 years]

   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.

3. Aim 3 - Dysplasia Detection Sensitivity and Specificity [5 years]

   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.

Secondary Outcome Measures

1. Aim 1 - Screening Population Predictive Value [5 years]

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

2. Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure [5 years]

   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).

3. Aim 2 - Case/Control Population Sensitivity and Specificity [5 years]

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

4. Aim 3 - Dysplasia Detection Rate of Missed Dysplasia [5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria arm 1:

1. Male and female ages 50-85

2. Primary Care patients from Mayo Clinic Rochester or Mayo Clinic Health Systems.

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

Exclusion Criteria arm 1:

1. History of Barrett's esophagus or esophageal adenocarcinoma.

2. Prior endoscopy in the last 5 years.

3. Pregnant or lactating females.

4. Patients who are unable to consent.

5. Patients with current history of uninvestigated dysphagia

6. History of eosinophilic esophagitis, achalasia.

7. Patients on oral anticoagulation including Coumadin, Warfarin.

8. Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).

9. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).

10. Patients with history of known esophageal/gastric varices or cirrhosis.

11. Patients with history of esophageal resection due to carcinoma.

12. Patients with congenital or acquired bleeding diatheses.

13. Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.

14. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

15. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Inclusion criteria arm 2:

1. Subjects with known or suspected BE (cases). 1. Patient between the ages 18 - 90. 2. Patients with a BE segment ≥ 1cm in maximal extent endoscopically. 3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.

2. Undergoing clinically indicated endoscopy.

3. Subjects without known history of BE (controls). 1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria arm 2:

1. Subjects with known BE.

2. Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection (EMR)/endoscopic submucosal dissection (ESD) alone will not be excluded.

3. Patients with history of esophageal resection for esophageal carcinoma.

4. Subjects with or without known evidence of BE (on history or review of medical records).

5. Pregnant or lactating females. 3. Patients who are unable to consent. 4. Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study).

6. History of eosinophilic esophagitis, achalasia. 6. Patients on oral anticoagulation including Coumadin, Warfarin. 7. Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.

7. Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the sponge procedure.

8. Patients with history of known esophageal or gastric varices or cirrhosis. 10. Patients with history of esophageal or gastric resection. 11. Patients with congenital or acquired bleeding diatheses. 12. Patients with a history of esophageal squamous dysplasia. 13. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

9. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona	Scottsdale	Arizona	United States	85259
2	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
3	Mayo Clinic Health Systems - Austin	Austin	Minnesota	United States	55912
4	Mayo Clinic Health Systems - Mankato	Mankato	Minnesota	United States	56001
5	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
6	Northwell Health	New Hyde Park	New York	United States	11040

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Prasad G Iyer, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Prasad G. Iyer, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03961945
• Other Study ID Numbers: 19-002629
• First Posted: May 23, 2019
• Last Update Posted: Oct 4, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Prasad G. Iyer, Principal Investigator, Mayo Clinic: Barrett's Esophagus; Gastroesophageal Reflux; Reflux; Esophageal Cancer; Esophageal Adenocarcinoma
• Additional relevant MeSH terms: Adenocarcinoma; Barrett Esophagus; Esophageal Neoplasms

Study Results

No Results Posted as of Oct 4, 2021