# US 11,029,313 B2 · Method of treating cervical neoplasia in patients infected with human papilloma virus > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,029,313 B2 - Document ID: US11029313B2 - Status: Granted - Kind: B2 - Application number: 15/888,662 - Filed: 2018-02-05 - Published: 2018-06-21 - Granted: 2021-06-08 - Earliest claimed: 2008-09-26 - Assignees: The General Hospital Corporation; Imperial College of Science, Technology and Medicine - Applicants: The General Hospital Corporation; Imperial College of Science, Technology and Medicine - Inventors: Mark C. Poznansky; Hajah Siti Fatimah Jaafar; Dulcie V. Coleman; Pierre LeBlanc - Web page: https://patentgrep.com/patent/US11029313B2 ## CPC - G01N 33/5758: {involving compounds serving as markers for tumours, cancers or neoplasias, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides or metabolites} - G01N 33/575: for cancer - G01N 33/57545: of the ovaries - G01N 33/5755: of the uterine cervix, uterine corpus or endometrium - G01N 33/5759: {involving compounds localised on the membrane of tumour or cancer cells} - G01N 2333/025: Papovaviridae, e.g. papillomavirus, polyomavirus, SV40, BK virus, JC virus - G01N 2333/522: Alpha-chemokines, e.g. NAP-2, ENA-78, GRO-alpha/MGSA/NAP-3, GRO-beta/MIP-2alpha, GRO-gamma/MIP-2beta, IP-10, GCP-2, MIG, PBSF, PF-4 or KC - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - G01N 2800/56: Staging of a disease; Further complications associated with the disease - 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 The invention generally features compositions and methods for the diagnosis, treatment, and monitoring of neoplasia in a subject, as well as methods of treatment selection. ## Claims ### Claim 1 A method for treating cervical neoplasia in a subject infected with human papilloma virus (HPV), the method comprising: (a) detecting an HPV status from a cervical sample obtained from the subject, wherein the HPV is HPV type 6, 11, 16, 18, 31, 33, and/or 51; (b) measuring a level of a CXCL12 polypeptide having a molecular weight greater than about 10 kD or 11 kD in a cervical neoplasia sample of the subject; (c) comparing the level of the CXCL12 polypeptide in the cervical neoplasia sample of the subject to a first reference level and a second reference level; and (d) administering a less aggressive treatment to the subject identified as having a pre-invasive cervical neoplasia, wherein the pre-invasive cervical neoplasia comprises a level in the cervical neoplasia sample above the first reference level and below the second reference level, or administering a more aggressive treatment to the subject identified as having an invasive stage of cervical neoplasia, wherein the invasive stage of cervical neoplasia comprises a level in the cervical neoplasia sample above both the first reference level and the second reference level, wherein the first reference level is an increase of less than about 3-fold compared to a control sample; wherein the second reference level is an increase of more than 3-fold compared to the control sample; wherein the less aggressive treatment regimen is selected from the group consisting of loop electrical excision procedure (LEEP), trachelectomy, and hormonal therapy; and wherein the more aggressive treatment regimen is selected from the group consisting of hysterectomy, radiation therapy, and chemotherapy; thereby treating the cervical neoplasia in the subject. ### Claim 2 (depends on 1) The method of claim 1, wherein the HPV status is cervical intraepithelial neoplasia-2 (CIN2). ### Claim 3 (depends on 1) The method of claim 1, wherein the second reference level is an increase of higher than 5-fold compared to the control sample. ### Claim 4 (depends on 1) The method of claim 1, wherein the increased level of CXCL12 polypeptide indicates an increased clinical aggressiveness of the cervical neoplasia. ### Claim 5 (depends on 1) The method of claim 1, wherein the method further involves detecting CD3-expressing T cells. ### Claim 6 (depends on 1) The method of claim 1, wherein the first reference level or the second reference level is the level of CXCL12 present in the control sample. ### Claim 7 (depends on 1) The method of claim 1, wherein the first reference level or the second reference level is derived from a healthy control subject. ### Claim 8 (depends on 1) The method of claim 1, wherein the increase in the level of CXCL12 identifies a propensity for the cervical neoplasia to develop into an invasive cervical carcinoma. ### Claim 9 (depends on 1) The method of claim 1, wherein CXCL12 molecular weight is determined in an immunoassay, in an SDS-PAGE assay, by mass spectroscopy, by Western blot, or ELISA. ### Claim 10 (depends on 1) The method of claim 1, wherein the CXCL12 polypeptide selectively binds a CXCL12-specific antibody. ### Claim 11 (depends on 1) The method of claim 1, wherein the CXCL12 polypeptide has at least about 85% identity to the amino acid sequence of any of SEQ ID NOs: 2-7. ### Claim 12 (depends on 1) The method of claim 1, wherein the control sample is from a healthy control subject. ### Claim 13 (depends on 1) The method of claim 1, wherein the control sample is from a sample obtained from the subject prior to treatment. ### Claim 14 (depends on 1) The method of claim 1, wherein the HPV status is cervical intraepithelial neoplasia-3 (CIN3). ### Claim 15 (depends on 1) The method of claim 1, wherein the HPV status is invasive squamous cell carcinoma (INV, SCC).