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

Обзор

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.

Подробное описание

The sponge on a string (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 the SOS device to enable detection in Barrett's Esophagus and prevalent dysplasia/adenocarcinoma detection.

Вмешательства

• Устройство Sponge Capsule
  Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.

Первичные конечные точки

• Aim 1 - Screening Population [Срок оценки: 5 years]
• Aim 2 - Case/Control Population BE Detection [Срок оценки: 5 years]
• Aim 3 - Dysplasia Detection Sensitivity and Specificity [Срок оценки: 5 years]

Вторичные конечные точки (4)

• Aim 1 - Screening Population Predictive Value [Срок оценки: 5 years]
• Aim 1 - Screening Population Safety and Tolerability of sponge capsule procedure [Срок оценки: 5 years]
• Aim 2 - Case/Control Population Sensitivity and Specificity [Срок оценки: 5 years]
• Aim 3 - Dysplasia Detection Rate of Missed Dysplasia [Срок оценки: 5 years]

Критерии участия

Inclusion Criteria Aim1:

• Male and female ages 50-85
• Patients who have three or more risk factors for Barrett's Esophagus.
• Gastroesophageal reflux disease defined by:

• Diagnosis
• Use of one of the following drugs >= 3 months over the last 5 years: omeprazole, esomeprazole, pantoprazole, rabeprazole, dexlansoprazole, lansoprazole, ranitidine, famotidine, cimetidine
• prior endoscopic diagnosis of erosive esophagitis
• Body mass index (BMI) >= 30

Exclusion Criteria Aim1 and Aim 3:

• Previous history of:

• esophageal adenocarcinoma/cancer
• esophageal squamous carcinoma
• endoscopic ablation for Barrett's esophagus
• esophageal squamous dysplasia
• Current treatment with oral anticoagulation including Warfarin, Coumadin
• History of cirrhosis
• History of esophageal/gastric varices
• History of Barrett's esophagus
• Prior endoscopy in the last 5 years

Inclusion criteria Aim 2 and Aim 3:

• Subjects with known or suspected BE (cases).

• Patient between the ages 18 - 90.
• Patients with a BE segment ≥ 1cm in maximal extent endoscopically or suspected BE in medical record.
• Histology showing evidence of intestinal metaplasia with or without presence of dysplasia or suspected BE in medical record.
• Undergoing clinically indicated endoscopy.
• Subjects without known history of BE (controls).

• Undergoing clinically indicated diagnostic endoscopy.

Exclusion criteria Aim 2:

• 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.
• For subjects with or without known evidence of BE (on history or review of medical records):

• Pregnant or lactating females.
• Patients who are unable to consent.
• Patients with current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study).
• History of eosinophilic esophagitis, achalasia.
• Patients on oral anticoagulation including Coumadin, Warfarin (this does not apply to the brushings/biopsies only portion of the study).
• Patients on antiplatelet agents including Clopidogrel, unless discontinued for three to five days prior to the sponge procedure.
• 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 sponge procedure.
• Patients with history of known esophageal or gastric varices or cirrhosis.
• Patients with history of surgical esophageal resection for esophageal carcinoma.
• Patients with congenital or acquired bleeding diatheses.
• Patients with a history of esophageal squamous dysplasia.
• Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
• Patient has received chemotherapy class drugs or radiation to treat mediastinal or esophageal cancer.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 9 центров

• Mayo Clinic Arizona — Scottsdale
• Mayo Clinic Jacksonville — Jacksonville
• Mayo Clinic Health Systems - Austin — Austin
• Mayo Clinic Health Systems - Mankato — Mankato
• Mayo Clinic Rochester — Rochester
• Northwell Health — New Hyde Park
• Baylor Scott & White Research Institute — Dallas
• Mayo Clinic Health System-Eau Claire — Eau Claire
• … и ещё 1 центр

Идентификаторы

NCT: NCT03961945 · 19-002629 · R01CA241164 · NCI-2021-14395

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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