Clinical trial · Observational
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma
Minimally Invasive Molecular Approaches for the Detection of Barrett's Esophagus- High Grade Dysplasia and Esophageal Adenocarcinoma- Renewal Grant Aim 2 (The SOS6C Trial)
NCT07212491CI-TRIAL-00110658enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational
- description
- Patients undergo capsule sponge assessment over 5-10 minutes prior to standard of care endoscopy. Patients also undergo biopsy and esophageal brushing sample collection and complete questionnaires on study.
- interventionNames
- Other: Non-Interventional Study
Primary outcomes (2)
- measure
- Sensitivity of deoxyribonucleic acid (DNA) markers
- timeFrame
- Baseline
- description
- Will evaluate the sensitivity of DNA makers (methylated DNA markers ± aneuploidy) to distinguish between high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) and non-dysplastic Barrett's esophagus (BE).
- measure
- Specificity of DNA markers
- timeFrame
- Baseline
- description
- Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.