# US 2019/0169691 A1 · Heritable epigenetic modifications as markers of chemotherapy exposure

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- Number: US 2019/0169691 A1
- Document ID: US20190169691A1
- Status: Published application
- Kind: A1
- Application number: 16/274,579
- Filed: 2019-02-13
- Published: 2019-06-06
- Earliest claimed: 2016-03-01
- Assignees: Washington State University; Seattle Children's Hospital DBA Seatlle Children's Research Institute
- Applicants: Washington State University; Seattle Children's Hospital DBA Seatlle Children's Research Institute
- Inventors: Michael K. Skinner; Margarett Shnorhavorian
- Web page: https://patentgrep.com/patent/US20190169691A1

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12Q 2600/154: Methylation markers
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

Provided herein are epigenetic modifications that are associated with prior exposure to chemotherapy agents. In particular, differential DNA methylation regions (DMRs) that are characteristic of, and can thus be used to identify and/or treat, a male subject who has undergone chemotherapy are provided. The DMRs are used to screen for pregnancy complications, infertility, and passage of heritable mutations to an infant.

## Claims

### Claim at position 1

1-10. (canceled)

### Claim 11

A method for the early intervention and treatment of a male subject who is suspected of or who has been exposed to chemotherapy treatment, comprising
obtaining at least one genomic DNA sequence from a semen sample from said male subject that has previously undergone chemotherapy treatment;
identifying the presence or absence of an epigenetic modification at one or more regions of said at least one genomic DNA, wherein said epigenetic modification comprises at least one differential DNA methylation region (DMR) associated with at least one gene as listed in table 9;
indicating that said subject is at high risk of infertility or of passing heritable mutations which can lead to pregnancy complications or mutations in an infant if said epigenetic modification is identified to be present in said at least one genomic DNA sequence; and
administering an appropriate treatment protocol to said subject determined to be at high risk of infertility or of passing heritable mutations which can lead to pregnancy complications or mutations in an infant.

### Claim 12 (depends on 11)

The method of claim 11, wherein said at least one gene comprises a plurality of genes as listed in table 9.

### Claim 13 (depends on 11)

The method of claim 11, wherein said chemotherapy agent is at least one of cisplatin and ifosfamide.

### Claim 14 (depends on 11)

The method of claim 11, wherein said male subject underwent chemotherapy treatment for a period of time at an age prior to reproduction.

### Claim 15 (depends on 11)

The method of claim 11, wherein said male subject underwent chemotherapy treatment for a period of time at an age from 14 and 20 years old.