US 12,449,420 B2
Use of circulating tumor cell mitotic index in cancer stratification and diagnostics
Daniel Adams, Basking Ridge, NJ (US); and Cha-Mei Tang, Potomac, MD (US)
Assigned to CREATV MICROTECH INC., Potomac, MD (US)
Filed by CREATV MICROTECH INC., Potomac, MD (US)
Filed on Oct. 18, 2021, as Appl. No. 17/503,872.
Application 17/503,872 is a continuation of application No. 15/576,472, granted, now 11,150,245, previously published as PCT/US2016/034261, filed on May 26, 2016.
Claims priority of provisional application 62/330,529, filed on May 2, 2016.
Claims priority of provisional application 62/166,499, filed on May 26, 2015.
Prior Publication US 2022/0034888 A1, Feb. 3, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/574 (2006.01); G01N 33/50 (2006.01)
CPC G01N 33/574 (2013.01) [G01N 33/5005 (2013.01); G01N 33/5091 (2013.01); G01N 33/57415 (2013.01); G01N 33/57423 (2013.01); G01N 33/5743 (2013.01); G01N 33/57434 (2013.01); G01N 33/57438 (2013.01); G01N 33/57446 (2013.01); G01N 2800/52 (2013.01); G01N 2800/56 (2013.01); G01N 2800/7028 (2013.01)] 13 Claims
 
1. A method for monitoring the effectiveness of treatment in a subject having cancer, wherein the method comprises:
(a) obtaining a first population of circulating tumor cells (CTCs) from a first biological sample of a subject having cancer,
(b) screening the first population for CTCs in a mitotic cell cycle phase,
(c) identifying CTCs of (b) in a mitotic cell cycle phase,
(d) administering a cancer treatment to the subject,
(e) obtaining a second population of CTCs from a second biological sample of the subject after treatment,
(f) screening the second population for CTCs in a mitotic cell cycle phase, and
(g) identifying CTCs of (f) in a mitotic cell cycle phase,
wherein CTCs in a mitotic cell cycle phase are identified using a nuclear stain selected from the group consisting of a DAPI dye, a Hoechst dye, a Sytox dye, and a propidium iodide dye, or a colorimetric stain selected from the group consisting of a H&E (hematoxylin and eosin) stain, hematoxylin, kernechtrot dye, methyl green, and methylene blue, and
wherein when an increase in the number of mitotic CTCs in the second population versus the first population or an increase in the mitotic index calculated for the second population versus the first population is found, the treatment is determined to be ineffective and an alternative cancer treatment is administered to the subject.