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

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.

Study Overview

• Status: Recruiting
• Conditions: Barrett Esophagus; Esophageal Adenocarcinoma
• Intervention / Treatment: Device: Sponge Capsule

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 Type: Interventional
• Enrollment (Estimated): 1350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Katelyn Valdez; Phone Number: 480-301-6542; Email: Valdez.Katelyn@mayo.edu
      • Principal Investigator: Francisco Ramirez, MD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Jacksonville
      • Principal Investigator: Herbert Wolfsen, MD
      • Contact: Kristen Lozano; Phone Number: 904-953-4725; Email: Lozano.Kristen@mayo.edu
  • Minnesota
    • Austin, Minnesota, United States, 55912
      • Recruiting
      • Mayo Clinic Health Systems - Austin
      • Contact: Ramona Lansing, RN; Phone Number: 507-538-4974; Email: lansing.ramona@mayo.edu
      • Principal Investigator: Eduardo Antpack, MD
    • Mankato, Minnesota, United States, 56001
      • Recruiting
      • Mayo Clinic Health Systems - Mankato
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Grace Dosanjh, M.D.
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Prasad G. Iyer, M.D.
      • Contact: Ramona Lansing, R.N.; Phone Number: 507-538-4974; Email: lansing.ramona@mayo.edu
  • New York
    • New Hyde Park, New York, United States, 11040
      • Recruiting
      • Northwell Health
      • Contact: Molly Stewart; Phone Number: 516-600-1443; Email: mstewart8@northwell.edu
      • Principal Investigator: Arvind Trindade, MD
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott & White Research Institute
      • Contact: Shamel Brown; Phone Number: 214-818-2528; Email: shamel.brown@bswhealth.org
      • Contact: Felicia Padilla; Phone Number: 214-820-1771; Email: Felicia.Padilla@BSWHealth.org
      • Principal Investigator: Vani Konda, MD
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54701
      • Recruiting
      • Mayo Clinic Health System-Eau Claire
      • Contact: Rebecca L. Schmidt, R.N.; Phone Number: 715-838-5137; Email: Schmidt.Rebecca2@mayo.edu
    • La Crosse, Wisconsin, United States, 54601
      • Recruiting
      • Mayo Clinic Health System-Franciscan Healthcare
      • Contact: Melissa Passe; Phone Number: 507-255-8693; Email: Passe.Melissa@mayo.edu
      • Principal Investigator: Sebastian G. Strobel, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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/endoscopy 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/endoscopy 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 or suspected BE in medical record.
   3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
   4. Undergoing clinically indicated endoscopy.
2. Subjects without known history of BE (controls). 1. Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria arm 2:

1. Subjects with known BE.

   1. 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.
   2. Patients with history of esophageal resection for esophageal carcinoma.

2. For subjects with or without known evidence of BE (on history or review of medical records):

   1. Pregnant or lactating females.
   2. Patients who are unable to consent.
   3. Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
   4. History of eosinophilic esophagitis, achalasia.
   5. Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
   6. 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.
   9. Patients with history of surgical esophageal resection for esophageal carcinoma.
   10. Patients with congenital or acquired bleeding diatheses.
   11. Patients with a history of esophageal squamous dysplasia.
   12. Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
   13. Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aim 1 - Screening Population	To measure the positive and negative predictive value of the sponge capsule Barrett's esophagus test in a screening population.	5 years
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.	5 years
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
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).	5 years
Aim 2 - Case/Control Population Sensitivity and Specificity	Validate specificity and sensitivity cut offs of a BE prediction algorithm in an independent patient cohort	5 years
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	5 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Prasad G. Iyer, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Estimated): January 2, 2026
• Study Completion (Estimated): January 2, 2027

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Reflux; Esophageal Cancer; Barrett's Esophagus; Gastroesophageal Reflux; Esophageal Adenocarcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Precancerous Conditions; Adenocarcinoma; Esophageal Neoplasms; Barrett Esophagus
• Other Study ID Numbers: 19-002629

Drug and device information, study documents

• 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