# US 12,007,394 B2 · Biomarker for prognosis of thyroid cancer

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- Number: US 12,007,394 B2
- Document ID: US12007394B2
- Status: Granted
- Kind: B2
- Application number: 16/638,157
- Filed: 2018-05-15
- Published: 2021-12-02
- Granted: 2024-06-11
- Earliest claimed: 2017-09-18
- Assignees: National Taiwan University
- Applicants: Chih-Yuan Wang
- Inventors: Chih-Yuan Wang; Tien-Chun Chang; Pei-Jie Huang
- Web page: https://patentgrep.com/patent/US12007394B2

## CPC

- A61P 35/00: Antineoplastic agents
- G01N 33/57585: {involving compounds identifiable in body fluids}
- G01N 33/57557: {of other specific parts of the body, e.g. brain}
- C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575)
- G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- 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)
- 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

The present disclosure provides a method of prognosis of thyroid cancer including obtaining an exosome from a subject who had received a therapy of thyroid cancer such as thyroidectomy, and detecting whether thyroglobulin is present in the exosome. Moreover, the present disclosure provides the use of urinary exosomal thyroglobulin in being a non-invasive, reproducible, convenient, serial, and accurate follow-up marker for patient with thyroid cancer.

## Claims

### Claim 1

A method of prognosis of thyroid cancer in a subject in need thereof, comprising:
obtaining an exosome from the subject who had received a therapy of thyroid cancer, wherein the exosome is isolated from urine;
detecting a trend of a level of thyroglobulin present in the exosome;
diagnosing the subject with recurrent thyroid cancer for prognosis when the presence of thyroglobulin in the exosome shows an increasing trend,
wherein the increasing trend is that within six months after the therapy of thyroid cancer, a serum thyroglobulin of the diagnosed subject is undetectable, while the urinary exosomal thyroglobulin of the diagnosed subject is detected at a level of 0.412 ng/mL to 9.29 ng/ml; and
administering a thyroid cancer treatment to the diagnosed subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject had been identified as a thyroid cancer patient.

### Claim 3 (depends on 1)

The method of claim 1, wherein the therapy of thyroid cancer is selected from the group consisting of total thyroidectomy, partial thyroidectomy, thyroid remnant ablation with radioactive iodine, target therapy and a combination thereof.

### Claim 4 (depends on 1)

The method of claim 1, further comprising isolating the exosome from the sample by size exclusion chromatography, density gradient centrifugation, differential centrifugation, nanomembrane ultrafiltration, immunoabsorbent capture, affinity purification, or microfluidic separation.

### Claim 5 (depends on 1)

The method of claim 1, wherein the thyroid cancer treatment is selected from the group consisting of radioactive iodine, target therapy, and a combination thereof.

### Claim 6 (depends on 1)

The method of claim 1, wherein the thyroid cancer is selected from the group consisting of follicular thyroid cancer, follicular variant papillary thyroid cancer, papillary thyroid cancer, medullary thyroid cancer, Hurthle cell cancer, anaplastic thyroid cancer, and a combination thereof.

### Claim 7 (depends on 6)

The method of claim 6, wherein the thyroid cancer is follicular thyroid cancer or papillary thyroid cancer.

### Claim 8 (depends on 1)

The method of claim 1, wherein the presence of thyroglobulin in the exosome is detected by peptide sequencing with mass spectrometry.

### Claim 9

A method of evaluating a therapy of thyroid cancer, comprising:
obtaining an exosome from a subject who had received the therapy of thyroid cancer, wherein the exosome is isolated from urine;
detecting a trend of a level of thyroglobulin present in the exosome,
wherein the level of thyroglobulin in the exosome is indicative of the efficacy of the therapy of thyroid cancer,
wherein the thyroglobulin showing an increasing trend in the exosome is indicative of thyroid cancer recurrence,
wherein the increasing trend is that within six months after the therapy of thyroid cancer, a serum thyroglobulin of the subject is undetectable, while the urinary exosomal thyroglobulin of the subject is detected at a level of 0.412 ng/ml to 9.29 ng/ml; and
administering a thyroid cancer treatment to the subject when the presence of thyroglobulin in the exosome is detected.

### Claim 10 (depends on 9)

The method of claim 9, wherein the therapy of thyroid cancer is selected from the group consisting of total thyroidectomy, partial thyroidectomy, thyroid remnant ablation with radioactive iodine, target therapy and a combination thereof.

### Claim 11 (depends on 9)

The method of claim 9, wherein the thyroid cancer treatment is selected from the group consisting of radioactive iodine, target therapy, and a combination thereof.