RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessment of a Minimally Invasive Collection Device for Molecular Analysis of Esophageal Samples for the Non-endoscopic Detection of Barrett's Esophagus with and Without Dysplasia

Quick Facts

Study Start:2023-10-16
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06071845

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects with known or suspected Barrett's esophagus (BE) (cases)
  2. * Patients between the ages of 18-90.
  3. * Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
  4. * Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
  5. * Undergoing clinically indicated endoscopy.
  6. * Subjects without known history of BE (controls)
  7. * Undergoing clinically indicated diagnostic endoscopy
  1. * For subjects with or without known evidence of BE (on history or review of medical records)
  2. * Pregnant or lactating females.
  3. * Patients who are unable to consent.
  4. * Patients with current history of uninvestigated dysphagia.
  5. * History of eosinophilic esophagitis, achalasia.
  6. * Patients on oral anticoagulation including Coumadin, Warfarin.
  7. * Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the Cytosponge procedure.
  8. * Patients on oral thrombin inhibitors including Dabigatran and oral factor Xa inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for three to five days prior to the Cytosponge procedure.
  9. * Patients with history of known esophageal or gastric varices or cirrhosis.
  10. * Patients with history of surgical esophageal resection for esophageal carcinoma.
  11. * Patients with congenital or acquired bleeding diatheses.
  12. * Patients with a history of esophageal squamous dysplasia.
  13. * Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
  14. * Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Prasad G. Iyer, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
Northwestern University
Chicago, Illinois, 60611
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Long Island Jewish Medical Center | Northwell Health
New Hyde Park, New York, 11040
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Prasad G. Iyer, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-10-16
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

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