Clinical trial NCT03961945: Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Official title: Minimally Invasive Molecular Approaches for the Diagnosis of Barrett's Esophagus and Esophageal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Barrett Esophagus
Esophageal Adenocarcinoma
Keywords: Barrett's Esophagus
Gastroesophageal Reflux
Reflux
Esophageal Cancer
Esophageal Adenocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-05-23
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aim 1 - Screening Population
timeFrame: 5 years
measure: Aim 2 - Case/Control Population BE Detection
timeFrame: 5 years
measure: Aim 3 - Dysplasia Detection Sensitivity and Specificity
timeFrame: 5 years
Secondary outcomes:
measure: Aim 1 - Screening Population Predictive Value
timeFrame: 5 years
measure: Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure
timeFrame: 5 years
measure: Aim 2 - Case/Control Population Sensitivity and Specificity
timeFrame: 5 years
measure: Aim 3 - Dysplasia Detection Rate of Missed Dysplasia
timeFrame: 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Austin
country: United States
facility: Mayo Clinic Health Systems - Austin
state: Minnesota
city: Mankato
country: United States
facility: Mayo Clinic Health Systems - Mankato
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Eau Claire
country: United States
facility: Mayo Clinic Health System-Eau Claire
state: Wisconsin
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Prasad G. Iyer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: