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Biomarker for ovarian cancerRelated Patent Categories: Chemistry: Molecular Biology And Microbiology, Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip, Involving Antigen-antibody Binding, Specific Binding Protein Assay Or Specific Ligand-receptor Binding Assay, Involving A Micro-organism Or Cell Membrane Bound Antigen Or Cell Membrane Bound Receptor Or Cell Membrane Bound Antibody Or Microbial Lysate, Animal Cell, Tumor Cell Or Cancer CellBiomarker for ovarian cancer description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070172902, Biomarker for ovarian cancer. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] The instant application claims the benefit of U.S. Provisional Application No. 60/693,324, filed Jun. 22, 2005, the entire contents of which provisional application are expressly incorporated herein by reference. FIELD OF THE INVENTION [0002] The invention provides for a biomarker important in the detection of ovarian cancer. The marker was identified by distinguishing the serum protein profile in ovarian cancer patients from healthy individuals using SELDI analysis. The present invention relates the biomarker to a system and method in which the biomarker is used for the qualification of ovarian cancer status. The present invention also identifies a biomarker as a known protein, CTAP3. BACKGROUND OF THE INVENTION [0003] Ovarian cancer is among the most lethal gynecologic malignancies in developed countries. Annually in the United States alone, approximately 23,000 women are diagnosed with the disease and almost 14,000 women die from it. (Jamal, A., et al., CA Cancer J. Clin, 2002; 52:23-47). Despite progress in cancer therapy, ovarian cancer mortality has remained virtually unchanged over the past two decades. (Id.) Given the steep survival gradient relative to the stage at which the disease is diagnosed, early detection remains the most important factor in improving long-term survival of ovarian cancer patients. [0004] The poor prognosis of ovarian cancer diagnosed at late stages, the cost and risk associated with confirmatory diagnostic procedures, and its relatively low prevalence in the general population together pose extremely stringent requirements on the sensitivity and specificity of a test for it to be used for screening for ovarian cancer in the general population. [0005] The identification of tumor markers suitable for the early detection and diagnosis of cancer holds great promise to improve the clinical outcome of patients. It is especially important for patients presenting with vague or no symptoms or with tumors that are relatively inaccessible to physical examination. Despite considerable effort directed at early detection, no cost effective screening tests have been developed (Paley P J., Curr Opin Oncol, 2001; 13(5):399-402) and women generally present with disseminated disease at diagnosis. (Ozols R F, et al., Epithelial ovarian cancer. In: Hoskins W J, Perez C A, Young R C, editors. Principles and Practice of Gynecologic Oncology. 3rd ed. Philadelphia: Lippincott, Williams and Wilkins; 2000. p. 981-1057). [0006] The best-characterized tumor marker, CA125, is negative in approximately 30-40% of stage I ovarian carcinomas and its levels are elevated in a variety of benign diseases. (Meyer T, et al., Br J Cancer, 2000; 82(9):1535-8; Buamah P., J Surg Oncol, 2000; 75(4):264-5; Tuxen M K, et al., Cancer Treat Rev, 1995; 21(3):215-45). Its use as a population-based screening tool for early detection and diagnosis of ovarian cancer is hindered by its low sensitivity and specificity. (MacDonald N D, et al., Eur J Obstet Gynecol Reprod Biol, 1999; 82(2):155-7; Jacobs I, et al., Hum Reprod, 1989; 4(1):1-12; Shih I-M, et al., Tumor markers in ovarian cancer. In: Diamandis E P, Fritsche, H., Lilja, H., Chan, D. W., and Schwartz, M., editor. Tumor markers physiology, pathobiology, technology and clinical applications. Philadelphia: AACC Press; in press). Although pelvic and more recently vaginal sonography has been used to screen high-risk patients, neither technique has the sufficient sensitivity and specificity to be applied to the general population. (MacDonald N D, et al., supra). Recent efforts in using CA125 in combination with additional tumor markers (Woolas R P X F, et al., J Natl Cancer Inst, 1993; 85(21):1748-51; Woolas R P, et al., Gynecol Oncol, 1995; 59(1):111-6; Zhang Z, et al., Gynecol Oncol, 1999; 73(1):56-61; Zhang Z, et al., Use of Multiple Markers to Detect Stage I Epithelial ovarian cancers: Neural Network Analysis Improves Performance. American Society of Clinical Oncology 2001; Annual Meeting, Abstract) in a longitudinal risk of cancer model (Skates S J, et al., Cancer, 1995; 76(10 Suppl):2004-10), and in tandem with ultrasound as a second line test (Jacobs I D A, et al., Br Med J, 1993; 306(6884):1030-34; Menon U T A, et al., British Journal of Obstetrics and Gynecology, 2000; 107(2):165-69) have shown promising results in improving overall test specificity, which is critical for a disease such as ovarian cancer that has a relatively low prevalence. [0007] Due to the dismal prognosis of late stage ovarian cancer, it is the general consensus that a physician will accept a test with a minimal positive predictive value of 10%. (Bast, R. C., et al., Cancer Treatment and Research, 2002; 107:61-97). Extending this to the general population, a general screening test would require a sensitivity greater than 70% and a specificity of 99.6%. Currently, none of the existing serologic markers, such as CA125, CA72-4, or M-CSF, individually delivers such a performance. (Bast, R. C., et al., Int J Biol Markers, 1998; 13:179-87). [0008] Thus, there is a critical need for new serological markers that individually or in combination with other markers or diagnostic modalities deliver the required sensitivity and specificity for early detection of ovarian cancer. (Bast R C, et al., Early detection of ovarian cancer: promise and reality ovarian cancer: ISIS Medical Media Ltd., Oxford, UK; 2001. in press). Without an acceptable screening test, early detection remains the most critical factor in improving long-term survival of patients with ovarian cancer. [0009] Thus, it is desirable to have a reliable and accurate method of determining the ovarian cancer status in patients, the results of which can then be used to manage subject treatment. SUMMARY OF THE INVENTION [0010] It has been found that CTAP3 is up-regulated in the serum of patients with ovarian cancer. Accordingly, the level of CTAP3 is useful as a biomarker in making a determination of ovarian cancer in a subject. Likewise, CTAP3-related proteins are useful as biomarkers for making a determination of ovarian cancer in a subject [0011] The present invention provides sensitive and quick methods and kits that are useful for determining the ovarian cancer status by measuring one or more specific biomarkers, e.g., CTAP3-related molecules such as CTAP3. The measurement of this marker in patient samples provides information that diagnosticians can correlate with a probable diagnosis of human cancer or a negative diagnosis (e.g., normal or disease-free). The marker is characterized by molecular weight and its known protein identity. The marker can be resolved from other proteins in a sample by using a variety of fractionation techniques, e.g., chromatographic separation coupled with mass spectrometry, protein capture using immobilized antibodies or by traditional immunoassays. In preferred embodiments, the method of resolution involves Surface-Enhanced Laser Desorption/Ionization ("SELDI") mass spectrometry, in which the surface of the mass spectrometry probe comprises adsorbents that bind the markers. [0012] The present invention provides a method of qualifying ovarian cancer status in a subject comprising measuring at least one biomarker including a CTAP3-related peptide, e.g., CTAP3, in a biological sample from the subject; and (b) correlating the measurement with ovarian cancer status. In certain methods, the measuring step comprises detecting the presence or absence of the marker in the sample. In other methods, the measuring step comprises quantifying the amount of marker in the sample. In other methods, the measuring step comprises qualifying the type of biomarker in the sample. [0013] The invention also relates to methods wherein the measuring step comprises: providing a subject sample of blood or a blood derivative; fractionating proteins in the sample on an anion exchange resin and collecting fractions that contain a CTAP3-related peptide, e.g., CTAP3, from the fractions on a surface of a substrate comprising capture reagents that bind this protein biomarkers. The blood derivative is, e.g., serum or plasma. In preferred embodiments, the substrate is a SELDI probe comprising an IMAC copper surface and wherein the protein biomarkers are detected by SELDI. In other embodiments, the substrate is a SELDI probe comprising biospecific affinity reagents that bind, for example, CTAP3 and wherein the protein biomarkers are detected by SELDI. In other embodiments, the substrate is a microtiter plate comprising biospecific affinity reagents that bind CTAP3 and the protein biomarker is detected by immunoassay. [0014] In certain embodiments, the methods further comprise managing subject treatment based on the status determined by the method. For example, if the result of the methods of the present invention is inconclusive or there is reason that confirmation of status is necessary, the physician may order more tests. Alternatively, if the status indicates that surgery is appropriate, the physician may schedule the patient for surgery. Furthermore, if the results show that treatment has been successful, no further management may be necessary. [0015] The invention also provides for such methods where the CTAP3-related biomarker is measured again after subject management, i.e., treatment. In these instances, the step of managing subject treatment is then repeated and/or altered depending on the result obtained. In further embodiments, the measurement is correlated with disease progression. [0016] The term "ovarian cancer status" refers to the status of the disease in the patient. Examples of types of ovarian cancer statuses include, but are not limited to, the subject's risk of cancer, the presence or absence of disease, the stage of disease in a patient, and the effectiveness of treatment of disease. Other statuses and degrees of each status are known in the art. [0017] In certain preferred embodiments, the method for qualifying ovarian cancer status further comprises measuring and correlating at least one biomarker selected from the group consisting of CA125, transferrin, haptoglobin, ApoA1, transthyretin, ITIH4 internal fragment, beta 2-microglobulin, hepcidin, prostatin, osteopontin, esoinophil-derived neurotoxin, leptin, prolactin, IGF-II, hemoglobin and modified forms thereof with ovarian cancer status. [0018] In other preferred embodiments, the method for qualifying ovarian cancer status further comprises measuring and correlating at least one biomarker selected from the group consisting of CA125 II, CA15-3, CA19-9, CA72-4, CA 195, tumor associated trypsin inhibitor (TATI), CEA, placental alkaline phosphatase (PLAP), Sialyl TN, galactosyltransferase, macrophage colony stimulating factor (M-CSF, CSF-1), lysophosphatidic acid (LPA), 110 kD component of the extracellular domain of the epidermal growth factor receptor (p110EGFR), tissue kallikreins, e.g., kallikrein 6 and kallikrein 10 (NES-1), prostasin, HE4, creatine kinase B (CKB), LASA, HER-2/neu, urinary gonadotropin peptide, Dianon NB 70/K, Tissue peptide antigen (TPA), SMRP, osteopontin, and haptoglobin, leptin, prolactin, insulin-like growth factor I and insulin-like growth factor II with ovarian cancer status. [0019] In one embodiment, the invention provides methods that comprise measuring the CTAP3 marker in conjunction with measuring CA125 or CA125 II in a biological sample from a subject and correlating the coordinated measurement with ovarian cancer status. We have found that measurement of CTAP3 in conjunction or combination with CA125 can provide enhanced results (e.g., enhanced discrimination or detection) than measurement of either marker alone. [0020] In another embodiment, the invention provides methods that comprise measuring the CTAP3 marker in a biological sample from a subject and correlating the measurement with ovarian cancer status, wherein the status is borderline ovarian cancer versus invasive ovarian cancer. We have found that CTAP3 can discriminate between borderline ovarian cancer versus invasive ovarian cancer Continue reading about Biomarker for ovarian cancer... Full patent description for Biomarker for ovarian cancer Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Biomarker for ovarian cancer patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Biomarker for ovarian cancer or other areas of interest. ### Previous Patent Application: Magnetic particle tagged reagents and techniques Next Patent Application: Diagnostic marker for cancer Industry Class: Chemistry: molecular biology and microbiology ### FreshPatents.com Support Thank you for viewing the Biomarker for ovarian cancer patent info. 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