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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Male and female ages 50-85

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

• Gastroesophageal reflux disease defined by:

‣ Diagnosis

⁃ Use of one of the following drugs \>= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine

⁃ prior endoscopic diagnosis of erosive esophagitis

• Body mass index (BMI) \>= 30

• Subjects with known or suspected BE (cases).

‣ Patient between the ages 18 - 90.

⁃ Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.

⁃ Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.

⁃ Undergoing clinically indicated endoscopy.

• Subjects without known history of BE (controls).

‣ Undergoing clinically indicated diagnostic endoscopy.

Locations
United States
Arizona
Mayo Clinic Arizona
COMPLETED
Scottsdale
Florida
Mayo Clinic Jacksonville
COMPLETED
Jacksonville
Minnesota
Mayo Clinic Health Systems - Austin
RECRUITING
Austin
Mayo Clinic Health Systems - Mankato
COMPLETED
Mankato
Mayo Clinic Rochester
RECRUITING
Rochester
New York
Northwell Health
COMPLETED
New Hyde Park
Texas
Baylor Scott & White Research Institute
COMPLETED
Dallas
Wisconsin
Mayo Clinic Health System-Eau Claire
RECRUITING
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
WITHDRAWN
La Crosse
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2027-01-02
Participants
Target number of participants: 1550
Treatments
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.
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.
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.
Authors
Sponsors
Leads: Mayo Clinic
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov