# US 2013/0280730 A1 · Canceration information providing method and canceration information providing device

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- Number: US 2013/0280730 A1
- Document ID: US20130280730A1
- Status: Published application
- Kind: A1
- Application number: 13/848,990
- Filed: 2013-03-22
- Published: 2013-10-24
- Earliest claimed: 2012-03-30
- Assignees: Sysmex Corporation
- Inventors: Ryuichiro EBI; Koki TAJIMA; Shigeki ABE
- Web page: https://patentgrep.com/patent/US20130280730A1

## CPC

- G01N 33/5091: {for testing the pathological state of an organism}
- G01N 15/147: {the analysis being performed on a sample stream}
- G01N 2015/0092: {Monitoring flocculation or agglomeration}
- G01N 2015/1488: {Methods for deciding}
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Provided is a canceration information providing method capable of presenting information related to canceration of cells with high reliability. A cell in which an amount of DNA is greater than or equal to an amount of DNA of a normal cell in a S period is extracted from a cell group of V11≦N/C ratio≦V12 (first counting step). If a number of cells obtained in the first counting step is greater than or equal to a threshold value S1 (S107: YES), “Cancer” is set to a flag 1. A cell in which an amount of DNA is 2C is extracted from a cell group of V13≦N/C ratio<V11 (second counting step). A ratio of a number of cells obtained in the first counting step and a number of cells obtained in the second counting step is calculated, and “Cancer” is set to a flag 2 if the ratio is greater than or equal to a threshold value S2 (S111: YES). If either one of the flags 1, 2 is “Cancer” (S113: YES), retest necessary is displayed.

## Claims

### Claim 1

A canceration information providing method for providing information related to canceration of cells, the method comprising:
acquiring information related to number of normal cells which are contained in a specimen including cells collected from an epidermal tissue and present on a surface layer side than at least basal cells in the epidermal tissue;
preparing a measurement specimen in which the normal cells present on the surface layer side than at least the basal cells in the epidermal tissue is contained by a target number based on the information related to the acquired number of normal cells;
acquiring first data related to an amount of DNA of the cell contained in the prepared measurement specimen;
acquiring number of first cells, each of which having an amount of DNA exceeding the amount of DNA of a normal cell in which a cell cycle is in a G0 period or a G1 period based on the first data; and
outputting information related to canceration of the cells based on the acquired number of first cells.

### Claim 2 (depends on 1)

The canceration information providing method according to claim 1, further comprising:
acquiring second data related to a size of a cell nucleus of the cell contained in the prepared measurement specimen, and third data related to a size of the cell, wherein
the step of acquiring the number of first cells includes:
calculating a ratio of the size of the cell nucleus with respect to the size of the cell based on the second data and the third data;
classifying the cells within a predetermined range in which the calculated ratio is greater than or equal to a predetermined threshold value into a first cell group; and
acquiring number of first cells, each of which having an amount of DNA exceeding an amount of DNA of the normal cell in which the cell cycle is in the G0 period or the G1 period based on the first data for the cells classified into the first cell group.

### Claim 3 (depends on 2)

The canceration information providing method according to claim 2, wherein the predetermined range is set with an upper limit and a lower limit.

### Claim 4 (depends on 2)

The canceration information providing method according to claim 2, further comprising:
acquiring a number of second cells in which the ratio of the size of the cell nucleus with respect to the size of the cell is smaller than the predetermined threshold value and each of which has an amount of DNA of the normal cell in which the cell cycle is in the G0 period or the G1 period based on the first data, the second data, and the third data; and
calculating a ratio of the acquired number of first cells and the acquired number of second cells, wherein
the step of outputting information related to the canceration of the cells includes:
outputting the information related to the canceration of the cells based on the number of first cells and the calculated ratio.

### Claim 5 (depends on 4)

The canceration information providing method according to claim 4, wherein
the step of acquiring the number of second cells includes:
classifying cells, in which the ratio of the size of the cell nucleus with respect to the size of the cell is smaller than the predetermined threshold value, into a second group based on the second data and the third data; and
acquiring the number of second cells, each of which having the amount of DNA of the normal cell in which the cell cycle is in the G0 period or the G1 period of the cells classified into the second cell group based on the first data.

### Claim 6 (depends on 1)

The canceration information providing method according to claim 1, further comprising:
determining one or more cells to be analyzed, which are a target to acquire the first data, from the cell group contained in the measurement specimen.

### Claim 7 (depends on 6)

The canceration information providing method according to claim 6, wherein
the step of determining includes:
classifying the cell group contained in the measurement specimen into one or more cells of the same type as the cells to be analyzed and one or more cells of a different type from the cells to be analyzed.

### Claim 8 (depends on 6)

The canceration information providing method according to claim 6, wherein
the step of determining includes:
classifying the cells of the same type as the cells to be analyzed into one or more aggregated cells and one or more non-aggregated cells; and
determining the classified non-aggregated cells as the cell to be analyzed.

### Claim 9 (depends on 6)

The canceration information providing method according to claim 6, further comprising:
prohibiting the output of the information related to the canceration of the cells when the number of cells to be analyzed determined in the determining step is smaller than or equal to a predetermined number.

### Claim 10 (depends on 1)

The canceration information providing method according to claim 1, further comprising:
irradiating the measurement specimen including cells collected from epidermal tissue with light; and
detecting optical information, wherein
the step of acquiring the first data includes:
acquiring the first data based on the detected optical information.

### Claim 11 (depends on 10)

The canceration information providing method according to claim 10, wherein
the step of detecting the optical information includes:
irradiating the measurement specimen flowing through a flow cell with light, wherein
the optical information includes scattered light information including a waveform of a scattered light intensity; and
the canceration information providing method further comprises:
acquiring third data related to a size of the cell based on a width of the waveform of the detected scattered light intensity.

### Claim 12 (depends on 1)

The canceration information providing method according to claim 1, wherein
the normal cells existing on the surface layer side than at least the basal cells in the epidermal tissue are surface layer cells and middle layer cells.

### Claim 13 (depends on 1)

The canceration information providing method according to claim 1, wherein
the epidermal tissue is uterine cervix.

### Claim 14 (depends on 1)

The canceration information providing method according to claim 1, wherein
the step of acquiring information related to the number of normal cells includes:
irradiating the measurement specimen including cells collected from epidermal tissue with light; and
detecting optical information, and
the canceration information providing method further comprises:
acquiring fourth data related to a size of the cell based on the detected optical information.

### Claim 15 (depends on 14)

The canceration information providing method according to claim 14, wherein
the step of detecting the optical information includes:
irradiating the measurement specimen flowing through a flow cell with light, wherein
the optical information includes scattered light information including a waveform of a scattered light intensity, and
the step of acquiring the fourth data includes:
acquiring the fourth data based on the scattered light information.

### Claim 16

A canceration information providing device for providing information related to canceration of cells, the device comprising:
a first detection unit for acquiring information related to number of normal cells which are contained in a specimen including cells collected from an epidermal tissue and present on a surface layer side than at least basal cells in the epidermal tissue;
a specimen preparing unit for preparing a measurement specimen in which the normal cells present on the surface layer side than at least the basal cells in the epidermal tissue is contained by a target number based on the information related to the number of normal cells acquired by the first detection unit; and
a controller configured for performing operations comprising:
acquiring data related to an amount of DNA of the cell contained in the measurement specimen prepared by the specimen preparing unit;
acquiring number of first cells, each of which having an amount of DNA exceeding the amount of DNA of a normal cell in which a cell cycle is in a G0 period or a G1 period based on the acquired data related to the amount of DNA; and
outputting information related to canceration of the cells based on the obtained number.

### Claim 17 (depends on 16)

The canceration information providing method according to claim 16, further comprising:
a second detection unit for irradiating the measurement specimen prepared by the specimen preparing unit with light and detecting optical information; wherein
the controller acquires the data related to the amount of DNA based on the detected optical information.

### Claim 18

A canceration information providing method for providing information related to canceration of cells, the method comprising:
acquiring information related to number of normal cells which are contained in a specimen including cells collected from an epidermal tissue and present on a surface layer side than at least basal cells in the epidermal tissue;
preparing a measurement specimen in which the normal cells present on the surface layer side than at least the basal cells in the epidermal tissue is contained by a target number based on the information related to the acquired number of cells;
acquiring data related to a ratio of a size of a cell nucleus with respect to a size of a cell for cells contained in the prepared measurement specimen;
acquiring number of cells within a defined range defining a range in which the ratio is greater than or equal to a predetermined value based on the acquired data; and
outputting information related to canceration of the cells based on the number of cells acquired in the acquiring step.

### Claim 19 (depends on 18)

The canceration information providing method according to claim 18, wherein
the data is obtained based on first data related to a size of a cell nucleus and second data related to a size of a cell.

### Claim 20 (depends on 18)

The canceration information providing method according to claim 18, wherein
the defined range is set with an upper limit and a lower limit.

### Claim 21

A canceration information providing device for providing information related to canceration of cells, the device comprising:
a first detection unit for acquiring information related to number of normal cells which are contained in a specimen including cells collected from an epidermal tissue and present on a surface layer side than at least basal cells in the epidermal tissue;
a specimen preparing unit for preparing a measurement specimen in which the normal cells present on the surface layer side than at least the basal cells in the epidermal tissue is contained by a target number based on the information related to the number of cells acquired by the first detection unit; and
a controller configured for performing operations comprising:
acquiring data related to a ratio of a size of a cell nucleus with respect to a size of a cell for cells contained in the measurement specimen prepared by the specimen preparing unit;
acquiring number of cells within a defined range defining a range in which the ratio is greater than or equal to a predetermined threshold value based on the data; and
outputting information related to canceration of the cells based on the obtained number of cells.

### Claim 22 (depends on 21)

The canceration information providing device according to claim 21, further comprising:
a second detection unit for irradiating the measurement specimen prepared by the specimen preparing unit with light and detecting optical information; wherein
the controller acquires the data related to the ratio of the size of the cell nucleus with respect to the size of the cell based on the detected optical information.