Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| BIOE | Other Identifier | University of Colorado |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether the EnteroTracker can obtain biomarkers that have been studied to be significant in screening BE and EAC. The current standard of care is endoscopic biopsy where the pathologist will visualize the tissue under a microscope to interpret diagnosis. Another goal of this study is to understand tolerance of the procedure so it might be used in an at-home setting.
This study seeks to determine the ability of a minimally invasive capsule-string device, the EnteroTracker®, to capture biomarkers associated with Barrett's Esophagus (BE) and Esophageal Adenocarcinoma (EAC). Identification of biomarkers in samples will support development of this simple-to-use, scalable, method for early screening of EAC, a cancer that accounts for the majority of esophageal cancers in the United States. In this study, the investigators plan to capture esophageal luminal content using the EnteroTracker® from patients with confirmed BE and/or EAC (test group) and healthy adults (control group). Samples will then be analyzed for series of biomarkers associated with BE and/or EAC. The investigators will test the hypothesis that the EnteroTracker® is able to capture biomarkers of interest in subjects with BE and EAC compared to healthy controls. To address this hypothesis, the investigators propose a pilot study with the following two specific aims. Evaluate the ability and tolerability of the EnteroTracker® to capture esophageal mucosal samples in adults with BE and/or EAC as well as controls and determine the ability of the EnteroTracker®-obtained BE/EAC biomarkers to distinguish between BE and/or EAC from control subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enterotracker | Experimental | The EnteroTracker® is a capsule device that includes an absorbent string. The trailing end of the string is taped to the cheek and the capsule is swallowed with 8-12 ounces of water. The capsule dislodges the string as it travels to the proximal small intestine. The capsule continues through the remainder of the GI tract, leaving a string in the esophagus, stomach, and duodenum. Following a 60-minute dwell time, the string is removed via the subjects' mouth and processed for analysis. Subjects will be coached to ease any potential anxieties and answer any questions. A preparatory video can be used for education if desired. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EnteroTracker | Device | The EnteroTracker® is a capsule device that includes an absorbent string. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study Esophageal Mucosal Samples using Enterotracker Device | Capture esophageal mucosal samples in at least 50% of the test subjects using the EnteroTracker®. | 2 years |
| Testing Tolerability via "Post-Procedure Tolerability Survey" | At least 50% of subjects describe the EnteroTracker® as "Satisfactory" from taking a "Post-Procedure Tolerability Survey". | 2 years |
| Testing difference in Biomarkers between Control and BE/EAC patients | At least one biomarker differentiated between BE/EAC patients and control subjects in at least 50% of test subjects. Samples will be analyzed for various biomarkers including proteins, DNA, RNA and/or methylation of DNA. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Studying DNA Collection using Enterotracker Device | Capture at least 1 µg of DNA from the EnteroTracker® obtained mucosal samples in at least 50% of the test subjects. | 2 years |
| Testing Symptoms via Follow Up Adverse Event assessment call |
Not provided
Inclusion Criteria:
Inclusion Criteria for Test Population (BE and EAC subjects):
Inclusion Criteria for Control Population (otherwise healthy adults with no evidence of BE or EAC or other esophageal cancer but with GERD) 4. Able to swallow a Tylenol sized capsule 5. 45 years of age or older
1. The majority of BE and EAC patients are age 50 years and older. Fewer than 15% of the cases are found in people younger than age 55. However current literature has suggested that there has been an increase in cases among 45-65 years old [47].
6. Apparently healthy or ≥5 years of:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sachin Wani, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
The EnteroTracker® is a capsule device that includes an absorbent string.
Not provided
Not provided
Not provided
Not provided
No more than 50% of subjects experienced more than one of the following side effects: nausea, choking, sore throat, vomiting, or chest pain.
| 2 years |
| Testing difference in Multiple Biomarkers between Control and BE/EAC patients | More than one biomarker differentiated between BE/EAC patients and control subjects in at least 50% of test subjects. Samples will be analyzed for various biomarkers including proteins, DNA, RNA and/or methylation of DNA. | 2 years |
| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |