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The Microenvironment in Barrett's Esophagus

Overview

Información sobre este estudio

This study aims to elucidate the relationship between the microbiome, inflammation, and the microenvironment in Barrett's esophagus (BE) and esophageal adenocarcinoma (EAC), with the end goal of developing a non-endoscopic testing strategy based on pathogenic factors to identify patients at highest risk for EAC. To accomplish this the investigators will enroll 100 patients with known BE (50 with dysplasia or EAC) and 50 subjects without BE undergoing upper endoscopy. Prior to endoscopy each subject will undergo three minimally invasive potential screening and surveillance tests: saliva (oral microbiome), breath test (exhaled volatile organic compounds), and tethered capsule sponge sampling (methylated DNA markers). The study will evaluate these novel tests in combination with clinical and anthropometric factors to describe an optimal strategy for BE screening and monitoring.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

(for BE patients)

  • History of histologically confirmed BE, defined as endoscopically-suspected BE with intestinal metaplasia with goblet cells on esophageal biopsies.
  • History of histologically confirmed Adenocarcinoma for Sub-aim 1 c.
  • Clinically able to tolerate an endoscopy and biopsies.
  • BE length M ≥ 2.
  • Taking proton pump inhibitors at least once daily for 3 months prior to enrollment.
  • Age ≥ 18 years old.

Exclusion Criteria:

  • History of gastric cancer.
  • Any prior chemotherapy for esophageal cancer.
  • History of gastric or esophageal surgery.
  • Use of antibiotics or systemic immunosuppressants within three months prior to the date of endoscopy (intranasal and inhaled steroids are allowed).
  • Known untreated esophageal stricture or uninvestigated dysphagia.
  • Inability to give informed consent.
  • (BE patients only) History of prior endoscopic therapy for BE except a history of prior EMR of focal lesions without subsequent ablative therapy is permitted.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Cadman Leggett, M.D.

Cerrado para la inscripción

Contact information:

Bryan Linn

(507)255-4631

Linn.Bryan@mayo.edu

Austin, Minn.

Investigador principal de Mayo Clinic

Eduardo Antpack Filho, M.D.

Cerrado para la inscripción

Contact information:

Bryan Linn

(507) 255-4631

Linn.Bryan@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20316801

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