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Enrolling by invitation NCT07212491

Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma

— Observational Barrett Esophagus Esophageal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-Interventional Study.
Who it may be relevant to
Registry conditions: Barrett Esophagus, Esophageal Adenocarcinoma. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)

Overview

This study explores the use of a minimally invasive screening tool (a sponge on a string device) to detect Barrett's esophagus and esophageal adenocarcinoma and to develop a laboratory test for the detection of Barrett's esophagus-high grade dysplasia and esophageal adenocarcinoma.

Interventions

  • Other Non-Interventional Study
    Non-interventional study

Primary outcome measures

  • Sensitivity of deoxyribonucleic acid (DNA) markers [Time frame: Baseline]
  • Specificity of DNA markers [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Patient between the ages 18 - 90
  • Patients with a BE segment >= 1cm in maximal extent endoscopically
  • Histology showing evidence of intestinal metaplasia with or without presence of dysplasia
  • Undergoing clinically indicated endoscopy

Exclusion criteria

  • Patients with a prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with a history of endoscopic mucosal resection alone will not be excluded
  • Patients with a history of esophageal or gastric resection for esophageal or gastric carcinoma
  • Subjects with known evidence of BE (on history or review of medical records)
  • Pregnant or lactating females
  • Patients who are unable to consent
  • Patients with a current history of uninvestigated dysphagia (this does not apply to the brushings/biopsies only portion of the study for RST/ARZ sites only)
  • History of eosinophilic esophagitis or achalasia
  • Patients on oral anticoagulation including Coumadin, and warfarin, unless discontinued for thee to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
  • Patients on antiplatelet agents including clopidogrel, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
  • Patients on oral thrombin inhibitors including dabigatran and oral factor X an inhibitor such as rivaroxaban, apixaban, and edoxaban, unless discontinued for three to five days prior to the sponge procedure. (This does not apply to the brushing/biopsy only portion of the study for RST/ARZ sites only)
  • Patients with a history of known esophageal or gastric varices or cirrhosis
  • Patients with a history of esophageal or gastric resection
  • 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
  • Patients with Familial Adenomatous Polyposis (FAP) or Lynch Syndrome

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 3 centers
  • Mayo Clinic in Arizona — Scottsdale
  • Mayo Clinic in Florida — Jacksonville
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07212491 · SOS6C · 25-000761 · R01CA241164

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗