Biomarkers for ovarian cancer
Inventors
Fung, Eric T. • Ueland, Frederick R. • van Nagell, J. R. • Depriest, Paul D. • Baron, Andre T.
Assignees
University of Kentucky Research Foundation • Aspira Womens Health Inc
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Publication Number
US-8465929-B2
Publication Date
2013-06-18
Expiration Date
Abstract
The present invention provides protein-based biomarkers and biomarker combinations that are useful in qualifying ovarian cancer status in a patient. In particular, the biomarkers of this invention are useful to classify a subject sample as ovarian cancer, ovarian cancer of low malignant potential, benign ovarian disease or other malignant condition. The biomarkers can be detected by SELDI mass spectrometry.
Core Innovation
The invention relates to a method for qualifying ovarian cancer status in a subject by measuring Calcyclin, Calgranulin C and Hepcidin biomarkers in an ovarian cyst fluid, urine, or serum sample. The method determines the presence, absence, or level of the measured biomarkers and correlates the measured results with ovarian cancer status.
The disclosure describes use with mass spectrometry and/or immunoassay for the biomarker measurements, including SELDI and ProteinChip arrays. Software-based correlation and classification concepts are described for biomarker profiles or fingerprints to rule in or rule out disease categories.
The correlated biomarker measurements can also be used for disease course management. When correlation indicates ovarian cancer, treatment management includes administering a chemotherapeutic agent to the subject, and after-management re-measurement and correlation of biomarker measurements with disease progression are described.
Claims Coverage
The independent claim covers qualifying ovarian cancer status by measuring three biomarkers in ovarian cyst fluid, urine, or serum and correlating the measurements with ovarian cancer status. One independent inventive concept is present, with dependent features narrowing measurement modality and linking the correlation outcome to exclusions, treatment management, and progression monitoring.
Measuring Calcyclin, Calgranulin C and Hepcidin to qualify ovarian cancer status
Measuring Calcyclin, Calgranulin C and Hepcidin in an ovarian cyst fluid, urine, or serum sample from the subject by mass spectrometry or immunoassay to determine the presence, absence, or level of the measured biomarkers.
Correlating biomarker measurements with ovarian cancer status
Correlating the measurements of the presence, absence, or level of the measured Calcyclin, Calgranulin C and Hepcidin biomarkers with ovarian cancer status.
SELDI probe capture and laser desorption-ionization mass spectrometry measurement
Measuring Calcyclin, Calgranulin C and Hepcidin by capturing them on an adsorbent surface of a SELDI probe and detecting them using laser desorption-ionization mass spectrometry.
Immunoassay measurement of selected biomarkers
Measuring Calcyclin and Hepcidin using an immunoassay.
Rule-out benign ovarian disease based on Calcyclin presence
The presence of calcyclin rules out benign ovarian disease.
Treatment management using chemotherapeutic agent based on correlation
When a measurement correlates with ovarian cancer, treatment management includes administering a chemotherapeutic agent to the subject.
Disease progression monitoring after subject management
Measuring Calcyclin, Calgranulin C, and Hepcidin after subject management and correlating the measurements with disease progression.
Overall, the claim coverage centers on qualifying ovarian cancer status by measuring Calcyclin, Calgranulin C and Hepcidin in ovarian cyst fluid, urine, or serum, correlating presence, absence, or level with ovarian cancer status, and refining the workflow through specified mass spectrometry or immunoassay modalities, explicit benign-disease exclusion based on Calcyclin, and downstream use for treatment management and disease progression monitoring.
Stated Advantages
Supports qualifying ovarian cancer status in a subject based on correlated biomarker measurements.
Allows ruling out benign ovarian disease based on calcyclin presence.
Supports treatment management when correlation indicates ovarian cancer by administering a chemotherapeutic agent.
Supports after-management monitoring by re-measuring biomarkers and correlating with disease progression.
Documented Applications
Qualifying ovarian cancer status in a subject using ovarian cyst fluid, urine, or serum samples and correlating biomarker measurements with ovarian cancer status.
Ruling out benign ovarian disease based on calcyclin presence.
Treatment management in which correlation indicates ovarian cancer and the method includes administering a chemotherapeutic agent.
Disease course monitoring by measuring Calcyclin, Calgranulin C, and Hepcidin after subject management and correlating the measurements with disease progression.
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