# US 11,994,513 B2 · Diagnostic and prognostic methods for estrogen-induced cancers > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,994,513 B2 - Document ID: US11994513B2 - Status: Granted - Kind: B2 - Application number: 17/041,981 - Filed: 2019-03-29 - Published: 2021-01-28 - Granted: 2024-05-28 - Earliest claimed: 2018-03-29 - Assignees: The University of Newcastle - Applicants: The University of Newcastle - Inventors: Pradeep S. Tanwar - Web page: https://patentgrep.com/patent/US11994513B2 ## CPC - C12Q 1/6886: for cancer (immunoassay for cancer G01N33/575) - G01N 33/5091: {for testing the pathological state of an organism} - G01N 33/575: for cancer - G01N 33/5755: of the uterine cervix, uterine corpus or endometrium - C12Q 2600/118: Prognosis of disease development - C12Q 2600/158: Expression markers - G01N 2333/916: acting on ester bonds (3.1), e.g. phosphatases (3.1.3), phospholipases C or phospholipases D (3.1.4) - G01N 2496/00: Reference solutions for assays of biological material - G01N 2800/7028: Cancer - 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 - 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 herein are methods for detecting an estrogen-induced cancer in a subject, for identifying a subject at risk of developing an estrogen-induced cancer and for determining or predicting prognosis for a subject with an estrogen-induced cancer. The methods of the disclosure comprise determining the level of expression of ALPPL2 in a biological sample, typically a blood sample, obtained from a subject. ## Claims ### Claim 1 A method for treating a subject determined to have an estrogen-induced cancer, the method comprising: (a) obtaining or having obtained a biological sample from the subject; (b) performing or having performed a biochemical assay on the biological sample to identify the subject as having a level of expression of placental-like alkaline phosphatase 2 (ALPPL2) in the biological sample that is greater than a threshold level from one or more reference samples and is indicative of a presence of the estrogen-induced cancer in the subject; and (c) administering a therapy to the subject identified in (b) that is capable of treating the estrogen-induced cancer, wherein the therapy comprises chemotherapy, surgery, or radiotherapy, wherein the estrogen-induced cancer is early-stage ovarian cancer or early-stage endometrial cancer. ### Claim 2 (depends on 1) The method according to claim 1, wherein the level of expression of ALPPL2 is a qualitative or quantitative determination of expression of an ALPPL2 protein or of ALPPL2 mRNA. ### Claim 3 (depends on 1) The method according to claim 1, wherein the method further comprises determining a statistical value derived from the level of expression of ALPPL2 from the sample obtained from the subject and the one or more reference samples and comparing said statistical values. ### Claim 4 (depends on 1) The method according to claim 1, wherein the biological sample obtained from the subject is a blood sample. ### Claim 5 (depends on 1) The method according to claim 1, wherein the elevated level of expression of ALPPL2 positively correlates with estrogen levels. ### Claim 6 (depends on 1) The method according to claim 1, wherein the estrogen-induced cancer is stage I ovarian cancer or stage I endometrial cancer. ### Claim 7 A method for monitoring the response of a subject to a therapeutic treatment for an estrogen-induced cancer, the method comprising: (a) obtaining from a subject a first biological sample; (b) identifying the subject as having a level of expression of placental-like alkaline phosphatase 2 (ALPPL2) in the first biological sample that is greater than a threshold level; (c) selecting a therapy capable of treating an estrogen-induced cancer, wherein the therapy comprises a chemotherapy, a surgery, or radiotherapy; (d) administering the selected therapy to the subject; (e) obtaining from the subject a second biological sample after (d); (f) identifying the subject as having a level of expression of ALPPL2 in the second biological sample that is greater than a threshold level; and (g) administering to the subject an additional therapy capable of treating an estrogen-induced cancer, wherein the additional therapy comprises a chemotherapy, a surgery, or radiotherapy, wherein the estrogen-induced cancer is early-stage ovarian cancer or early-stage endometrial cancer. ### Claim 8 (depends on 7) The method according to claim 7, further comprising obtaining and executing steps in respect of a third or subsequent sample. ### Claim 9 (depends on 7) The method according to claim 7, wherein the estrogen-induced cancer is stage I ovarian cancer or stage I endometrial cancer. ### Claim 10 A protocol for monitoring the efficacy of a therapeutic treatment for an estrogen-induced cancer, the protocol comprising: (a) obtaining from a subject a first biological sample; (b) identifying the subject as having a the-level of expression of placental-like alkaline phosphatase 2 (ALPPL2) in the first biological sample that is greater than a threshold level; (c) selecting a first therapy capable of treating an estrogen-induced cancer, wherein the first therapy is a chemotherapy, a surgery, or a radiotherapy; (d) administering the selected first therapy to the subject; (e) obtaining from the subject a second biological sample after (d); (f) determining a level of expression of ALPPL2 in the second biological sample; and (g) (i) if the level of expression of ALPPL2 in the second sample is at or greater than the threshold level, then administer a second therapy capable of treating estrogen-induced cancer to the subject, which is a different therapy than the first therapy, wherein the second therapy is a chemotherapy, a surgery, or a radiotherapy; and (ii) if the level of expression of ALPPL2 in the second sample is lower than the threshold level and the first therapy is a chemotherapy or a radiotherapy, then maintaining administration of the first therapy, wherein the estrogen-induced cancer is early-stage ovarian cancer or early-stage endometrial cancer. ### Claim 11 (depends on 10) The protocol according to claim 10, wherein the estrogen-induced cancer is stage I ovarian cancer or stage I endometrial cancer. ### Claim 12 (depends on 10) The protocol according to claim 10, further comprising obtaining and executing steps in respect of a third or subsequent sample.