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| Name | Class |
|---|---|
| Interpace Diagnostics Corporation | UNKNOWN |
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To evaluate association between mutational load (ML) from esophageal biopsy specimens in pre-endoscopic eradication therapy (EET) in Barrett's Esophagus (BE) or Intramucosal adenocarcinoma (IMC) patients and treatment resistance (treatment resistance will be defined as disease recurrence and/or need for additional intervention such as increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality).
Potential subjects will be identified via protocol and Institutional Review Board (IRB) methods prior to obtaining written informed consent. Once written informed consent is obtained, subjects will continue with planned routine care upper endoscopy. During the first study visit an upper endoscopy will be performed. At this visit, research specimens will be obtained for mutational load (ML) analysis and gastroenterologist (GI) pathologist diagnosis for the presence of adenocarcinoma or degrees of dysplasia. ML will be correlated to the pathology diagnosis on this research biopsy. Subjects will then undergo EET per routine standard of care at the treating institution until CEIM achieved. Subjects will be followed (data collection only) during treatment period until CEIM is achieved. After subjects reach CEIM, four additional research biopsies will be collected, from the midpoint of previous BE site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy: Barrett's Esophagus, Intramucosal adenocarcinoma | Other | Subjects will undergo standard of care (SOC) standard esophagogastroduodenoscopy (EGD) for the treatment of their condition (BE or IMC). Four (4) research biopsies will be taken from the midpoint of current disease. In cases where EMR (Endoscopic Mucosal Resection) is performed clinically, no research biopsies will be taken. Following CEIM, four (4) additional research biopsies will be collected, from the midpoint of previous BE site. Laboratory Biomarker Analysis: Correlative studies Esophagogastroduodenoscopy: Standard of care, research biopsies will be collected if clinical biopsies are taken |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Driven Procurement of Biopsies | Other | Four research biopsies collected at the midpoint of current BE or IMC at Baseline and after reaching CEIM. Biopsies will be used to calculate ML scores both pre and post EET. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Mean Mutational Load (ML) and Treatment Resistance | Treatment resistance will be assessed as a dichotomous variable and defined as those with one or more of the following features: disease recurrence, need for increased acid suppression, need for anti-reflux surgery, or use of alternate ablative modality. The association between pre-EET ML and treatment resistance will be calculated using the difference between the two mean ML values. | Baseline until Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Mutational Load and Dysplasia Category | The worst pathologic diagnosis at baseline will be recorded and ML between the three dysplasia groups (low grade dysplasia, high grade dysplasia, and esophageal adenocarcinoma) will be compared. | Day 1, at enrollment |
| Correlation of Mutational Load and Number of Ablation Sessions to CEIM |
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Inclusion Criteria:
No prior history of endoscopic treatment therapy for BE
Previously untreated "treatment naïve" disease history with confirmed histopathology analysis of at least one of the following:
BE lesion length of at least: C0, M1
At least 18 years of age at time of consent
Able and willing to provide written informed consent
Able and willing to comply with required study procedures and follow-up schedule
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas J Shaheen, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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Subjects will undergo a standard of care (SOC) esophagogastroduodenoscopy (EGD). At this visit, research biopsies will be obtained - 4 research biopsies at the midpoint of current Barrett's Esophagus (BE) OR slides will be cut from clinical Endoscopic Mucosal Resection (EMR). Slides will be analyzed for mutational load (ML) analysis and gastroenterologist (GI) pathologist diagnosis for the presence of adenocarcinoma or degrees of dysplasia. ML will be correlated to the pathology diagnosis on this research biopsy. Subjects will then undergo (Endoscopic Eradication Therapy) EET per routine standard of care at the treating institution until Complete Eradication of Intestinal Metaplasia (CEIM) is achieved. Subjects will be followed (data collection only) during treatment period until CEIM is achieved. After subjects reach CEIM, four additional research biopsies will be collected, from the midpoint of previous BE site.
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ML calculation will be compared to number of sessions required to achieve CEIM. |
| From Baseline until the date of first documentation of CEIM, assessed up to 24 Months |
| Correlation of Mutational Load and Stricture Formation | ML calculation will be compared to stricture rates. | From Baseline until the date of first documentation of CEIM, assessed up to 24 Months |