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| ID | Type | Description | Link |
|---|---|---|---|
| 25-000761 | Other Identifier | Mayo Clinic Institutional Review Board | |
| R01CA241164 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of deoxyribonucleic acid (DNA) markers | 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). | Baseline |
| Specificity of DNA markers | Will evaluate the specificity of DNA markers (methylated DNA markers ± aneuploidy) to distinguish between HGD/EAC and non-dysplastic BE. | Baseline |
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Inclusion Criteria:
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)
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Consecutive patients with a history of confirmed BE, undergoing clinically indicated endoscopy at Mayo Clinic Rochester, Mayo Clinic Florida, Mayo Clinic Arizona, Baylor Dallas, and University of Rochester, NY. Participants who meet inclusion/exclusion criteria but decline to participate in the capsule sponge procedure will have the option to participate in the esophageal brushing/biopsies only portion of the study (this option applies to Rochester and Arizona site only).
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| Name | Affiliation | Role |
|---|---|---|
| Prasad G. Iyer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Florida |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Samples retained with permission of participants
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| C562730 | Adenocarcinoma Of Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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