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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961945
• Other study ID #: 19-002629
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 2, 2027

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: January 2, 2027
• Est. primary completion date: January 2, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Device:
• Sponge Capsule
Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Locations

Country	Name	City	State
United States	Mayo Clinic Health Systems - Austin	Austin	Minnesota
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	Mayo Clinic Health System-Eau Claire	Eau Claire	Wisconsin
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Mayo Clinic Health System-Franciscan Healthcare	La Crosse	Wisconsin
United States	Mayo Clinic Health Systems - Mankato	Mankato	Minnesota
United States	Northwell Health	New Hyde Park	New York
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials