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US 12,516,379 B2Granted
Methods of using giant cell nucleic acid characterization in cancer screening, diagnostics, treatment and recurrence
AssigneeCreatv MicroTech, Inc.
InventorsDaniel Adams, Cha-Mei Tang
Life of this patent
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Abstract
The characterization of nucleic acids obtained from cancer-associated cells circulating in the blood of a subject, and the use of such characterizations in cancer screening, diagnostics, treatment, and recurrence, are disclosed.
Claims14
A method of determining cancer progression in a subject, said method comprising:
- (a) isolating giant cells, and optionally giant cell naked nuclei, from a biological sample of a subject having cancer,
- (b) determining the size of the giant cells and determining the number of cancer-associated mutations in the giant cells and/or giant cell naked nuclei, and
- (c) determining cancer is progressing in the subject based on changes in the size and the number determined in (b),
- wherein when the size of the giant cells increase and the number of the cancer-associated mutations increase, in comparison to the size of giant cells and the number of the cancer-associated mutations in giant cells and/or giant cell naked nuclei isolated from a sample obtained from the subject at an earlier time point, cancer is determined to be progressing in the subject,
- wherein the giant cells and giant cell naked nuclei are isolated from the biological sample using size exclusion methodology, and wherein the size exclusion methodology is a filter having a pore size that retains giant cells and giant cell naked nuclei of 8 microns and giant cells and giant cell naked nuclei greater than 8 microns, and
- wherein the giant cells are polynucleated cells ranging in size from 25-300 μm.
3 more elements
A method for predicting progression free survival (PFS) in a subject, said method comprising:
- (a) isolating giant cells, or giant cell naked nuclei, or both, from a biological sample of a subject having cancer,
- (b) determining the number of cancer-associated mutations in the giant cells and giant cell naked nuclei, wherein the mutations are determined in each of the following group of genes:
- ABL1, IDH2, FGFR1, PTEN, EGFR, AKT1, JAK2, FGFR2, RB1, ERBB2, ALK, JAK3, FGFR3, RET, ERBB4, APC, KDR, FLT3, SMAD4, EZH2, ATM, KIT, GNA11, SMARCB1, FBXW7, BRAF, KRAS, GNAQ, SMO, NPM1, CDH1, MET, GNAS, SRC, NRAS, CDKN2A, MLH1, HNFlA, STK11, PDGFRA, CSF1R, MPL, HRAS, TP53, PIK3CA, CTNNB1, NOTCH1, IDH1, VHL and PTPN11, and
- (c) predicting PFS in the subject based on changes in the number determined in (b),
- wherein when the number of cancer-associated mutations is determined to be three or less, the subject is predicted to have a greater likelihood of longer PFS than a subject having four or more cancer-associated mutations,
- wherein the giant cells and giant cell naked nuclei are isolated from the biological sample using size exclusion methodology, and wherein the size exclusion methodology is a filter having a pore size that retains giant cells and giant cell naked nuclei of 8 microns and giant cells and giant cell naked nuclei greater than 8 microns, and
- wherein the giant cells are polynucleated cells ranging in size from 25-300 μm.
4 more elements
Dependencies are inferred from the claim text.