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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT03961945
Status
Recruiting
Apply to this trial

Conditions

  • Barrett Esophagus
  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2021
Status verified
Jan 2026
Primary completion
Jul 30, 2030
Completion
Jul 30, 2030

Study Design

Enrollment
1,550 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Aim 1 - Screening Population [ Time Frame: 5 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Mayo Clinic Health Systems - AustinAustinMinnesota55912
Ramona Lansing, RN
[email protected]
507-538-4974
Eduardo Antpack, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Health Systems - MankatoMankatoMinnesota56001-
Mayo Clinic RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Ramona Lansing, R.N.
[email protected]
507-538-4974
Prasad G. Iyer, M.D. (PRINCIPAL_INVESTIGATOR)
Northwell HealthNew Hyde ParkNew York11040-
Baylor Scott & White Research InstituteDallasTexas75246-
Mayo Clinic Health System-Eau ClaireEau ClaireWisconsin54701
Rebecca L. Schmidt, R.N.
[email protected]
715-838-5137
Mayo Clinic Health System-Franciscan HealthcareLa CrosseWisconsin54601-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic Arizona· Scottsdale, AZMayo Clinic Jacksonville· Jacksonville, FLMayo Clinic Health Systems - Austin· Austin, MNMayo Clinic Health Systems - Mankato· Mankato, MNMayo Clinic Rochester· Rochester, MNNorthwell Health· New Hyde Park, NY

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