Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT06071845
Status
Recruiting
Apply to this trial

Conditions

  • Barrett Esophagus
  • Barrett's Esophagus Without Dysplasia
  • Barretts Esophagus With Dysplasia
  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytosponge Procedure — DEVICE
    Investigators will follow the Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.
  • Endoscopic Assessment — DIAGNOSTIC_TEST
    Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Study Details

This clinical trial evaluates the use of cytosponge, a minimally invasive collection device, for the detection of Barrett's esophagus (BE) in patients undergoing endoscopy. Non-endoscopic swallowable encapsulate sponge cell collection devices combined with markers for BE/esophageal adenocarcinoma (EAC) detection are a guideline-endorsed alternative to endoscopy for BE screening. The Oncoguard registered trademark Esophagus test (OGE) test uses esophageal cytology specimens collected with a minimally invasive, non-endoscopic, encapsulated sponge sampling device to identify BE/EAC biomarkers that indicate whether a patient should undergo diagnostic endoscopy. The OGE test is a simple and cost effective screening method that may lower barriers to widespread adoption of BE screening in at risk patients, resulting in increased and earlier detection of BE/EAC.

Key Dates

Start date
Oct 16, 2023
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Known or Suspected Barrett's Esophagus (Case Arm)
    Investigators will follow Cytosponge Cell Collection Kit Instructions for Use to administer and retrieve the Cytosponge device.c. After the sponge is retrieved, it will then be placed in a vial of cell preservative solution (PN DD-13631, Exact Sciences, Madison, WI) and shipped to the Exact Sciences laboratory for further processing and subsequent analysis.
  • Active Comparator: No Known Barrett's Esophagus (Control Arm)
    Participants will undergo a diagnostic clinically indicated sedated endoscopy with standard endoscopic equipment.

Primary Outcome Measure

DNA yield from esophageal cytology samples collected with the Cytosponge device [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Prasad Iyer, MD (PRINCIPAL_INVESTIGATOR)
Allon Kahn, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224
Clinical Trials Referral Office
[email protected]
855-776-0015
Herbert C. Wolfsen, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611-
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Prasad G. Iyer, MD (PRINCIPAL_INVESTIGATOR)
Long Island Jewish Medical Center | Northwell HealthNew Hyde ParkNew York11040-

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