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

  • STATUS
    Recruiting
  • End date
    Jan 2, 2027
  • participants needed
    1350
  • sponsor
    Mayo Clinic
Updated on 10 October 2021
gastroesophageal reflux
endoscopy
reflux
esophageal adenocarcinoma
dysplasia
adenocarcinoma
intestinal metaplasia
metaplasia
Accepts healthy volunteers

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.

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.

Details
Condition Precancerous Conditions, BARRETT'S ESOPHAGUS, Barrett's Esophagus, Esophageal Diseases, Precancerous condition, Esophageal Disorders, adenocarcinoma of esophagus, Esophageal Adenocarcinoma
Treatment Sponge capsule
Clinical Study IdentifierNCT03961945
SponsorMayo Clinic
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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. 3. Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
Subjects without known history of BE (controls). 1. Undergoing clinically indicated diagnostic endoscopy
Undergoing clinically indicated endoscopy

Exclusion Criteria

Subjects with known BE
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
Patients with history of esophageal resection for esophageal carcinoma
Subjects with or without known evidence of BE (on history or review of medical records)
Pregnant or lactating females. 3. Patients who are unable to consent. 4. Patients with current history of uninvestigated dysphagia (this does not apply to the brushings only portion of the study)
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 sponge procedure
Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer
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
Patients with history of known esophageal or gastric varices or cirrhosis. 10. Patients with history of esophageal or gastric resection. 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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