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

Overview

Información sobre este estudio

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.

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:

  • All participants will be 50 years of age or older and younger than 85 years of age. 
  • All participants will be stratified into those with or without gastroesophageal reflux disease (defined as symptoms of heartburn or acid regurgitation more than once a week, or taking proton pump inhibitors for more than 3 months, or those with the diagnosis of gastroesophageal reflux disease in the diagnostic index, or those with endoscopic evidence of esophagitis).
  • Other risk factors considered would include:
    • Caucasian race;
    • History of ever smoking (current or prior history of smoking);
    • BMI greater than equal to 30;
    •  Family history of Barrett's esophagus or esophageal adenocarcinoma;
    •  Male sex.

Exclusion Criteria:

  • History of Barrett's esophagus or esophageal adenocarcinoma.
  • Prior endoscopy in the last 10 years.
  • Pregnant or lactating females.
  • Patients who are unable to consent.
  • Patients with current history of uninvestigated dysphagia
  • History of eosinophilic esophagitis, achalasia.
  • Patients on oral anticoagulation including Coumadin, Warfarin.
  • Patients on antiplatelet agents including Clopidogrel (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
  • Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban (Visit 1), unless discontinued for three to five days prior to the sponge procedure (Visit 2 and 3).
  • Patients with history of known varices or cirrhosis.
  • Patients with history of esophageal or gastric resection.
  • Patients with congenital or acquired bleeding diatheses.
  • Patients with a history of esophageal squamous dysplasia or esophageal squamous carcinoma.
  • Identification of patients meeting inclusion and exclusion criteria was done using two institutional EMR search tools (i2b2 and ACE) using ICD and CPT codes listed below along with NLP for some terms.

 

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

Prasad Iyer, M.D., M.S.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Investigador principal de Mayo Clinic

Prabhjot Dosanjh, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Investigador principal de Mayo Clinic

Sebastian Strobel, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Investigador principal de Mayo Clinic

Herbert Wolfsen, M.D.

Abierto para la inscripción

Contact information:

Herbert Wolfsen M.D.

(904)953-6970

Wolfsen.Herbert@mayo.edu

Eau Claire, Wis.

Investigador principal de Mayo Clinic

Sushil Kumar Garg, M.B.B.S.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Austin, Minn.

Investigador principal de Mayo Clinic

Eduardo Antpack Filho, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Francisco Ramirez, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

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CLS-20461792

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