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US 10,255,410 B2Granted
Methods for treating Barrett's metaplasia and esophageal adenocarcinoma
AssigneeInterpace Diagnostics Corporation
InventorsEric Matthew Gayle Ellsworth, Sydney David Finkelstein, Sara Ann Jackson, Brendan Corcoran, Dennis Morgan Smith, Jr.
Life of this patent
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Abstract
Disclosed herein are methods for treating Barrett's metaplasia and esophageal adenocarcinoma and methods for determining mutational load as a predictor of the risk of disease progression from Barrett's metaplasia to esophageal adenocarcinoma.
Claims30
A method, the method comprising:
- amplifying DNA sequences from a biological specimen from a subject having Barrett's metaplasia;
- detecting the presence or absence of a mutation in microsatellite regions of 1q22, 1p34.2, 1p22.3, 1p36.21, 1p36.21, B Catenin E3, 3p25, 3p12.3, 3p22.3, 3p24.3, 3p26.3, 3p11.2, 3p24.2, C-KIT E11, C-KIT E17, 5q23.1, 5q23.2, BRAF E15, EGFR E 19, EGFR E 21, 7p12.3, 7p12.1, 9p21.1, 9p23, 10q23.32, 10q23.33, HRAS1 E1, Kras2.E1, Kras2.E2, 17q22, 17q21.2, 17q11.2, 17p13.1 17p13, 17p13.1, 18q21.33, 19q13.2, 19q13.32, 21q21.2, 22q13.2, and Xp22.2 present in the amplified DNA sequences;
- categorizing clonality of each mutation;
- calculating a mutational load based on the sum of low and high clonality mutations;
- comparing the mutational load with a series of pre-determined mutational load cut-offs defining risk categories;
- assigning the subject to a risk category corresponding to the subject's mutational load, wherein each risk category is indicative of the risk of disease progression;
- determining if the subject is in a high risk category for disease progression from Barrett's metaplasia to esophageal adenocarcinoma;
- and
- administering to the subject identified in the high risk category at least one treatment modality selected from endoscopic mucosal resection, endoscopic submucosal dissection, a therapeutically effective amount of radiofrequency ablation, a therapeutically effective amount of cryoablation, a therapeutically effective amount of photodynamic therapy and combinations thereof.
6 more elements
Dependencies are inferred from the claim text.