Methods for diagnosing and monitoring the progression of cancer by measuring soluble c-Met ectodomain
Inventors
Bottaro, Donald P. • Athauda, Gagani • Burgess, Teresa Lynn
Assignees
Amgen Inc • US Department of Health and Human Services
Publication Number
US-8304199-B2
Publication Date
2012-11-06
Expiration Date
2026-11-08
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Abstract
Methods for measuring c-Met levels in urine and blood samples are provided. Methods for diagnosis and prognosis evaluation for cancer are also provided.
Core Innovation
The invention provides methods for diagnosing cancer and monitoring its progression by measuring soluble c-Met ectodomain levels in biological samples such as urine and blood. It is based on the observation that tumor cells expressing c-Met shed more c-Met ectodomain than normal counterparts, and that the shedding increases with malignant phenotype. This shedding is quantifiable in biological samples before tumors are palpable and correlates with tumor volume, making it a practical indicator of malignancy and tumor burden.
The problem being solved is the need for a sensitive, cost-efficient screening test for c-Met that can be used not only for diagnosis but also for determining disease stage, prognosis, and assessing therapeutic efficacy. Current knowledge indicated c-Met overexpression in certain cancers but lacked a non-invasive, reliable method for clinical evaluation prior to this invention.
Claims Coverage
The patent includes two independent claim groups covering methods for monitoring cancer status and measuring response to cancer therapy by comparing soluble c-Met ectodomain concentrations in biological fluids over time.
Method of monitoring cancer status by measuring soluble c-Met ectodomain over time
Determining soluble c-Met ectodomain concentration in a first biological fluid from a patient at a first time point, determining it again in a second biological fluid of the same type at a later time point, and comparing the two concentrations to assess cancer status. Changes in levels indicate regression, progression, or stability of the cancer.
Method of measuring patient response to cancer therapy by soluble c-Met ectodomain levels
Measuring soluble c-Met ectodomain concentration in biological fluid samples from a patient before and after cancer therapy, comparing these levels to evaluate the patient's response. Decreases indicate positive response, increases or similarity indicate lack of or negative response.
The claims focus on non-invasive, temporal monitoring of soluble c-Met ectodomain in biological fluids such as urine or plasma to assess cancer progression, regression, or response to therapy, applicable to various cancers including urinary tract, metastatic, prostate, and breast cancers.
Stated Advantages
Provides a reliable and practical indicator of malignant potential and tumor burden early in tumor development, even before tumors become palpable.
Enables non-invasive monitoring of cancer progression and response to therapy through quantifiable measurements in urine and blood.
Offers a sensitive, cost-efficient screening tool for cancer diagnosis, prognosis, and therapeutic assessment.
Documented Applications
Diagnosing cancer in patients or identifying patients at increased risk of developing cancer by measuring soluble c-Met ectodomain levels in urine and blood plasma samples.
Monitoring the progression or regression of cancer by comparing soluble c-Met ectodomain concentrations in sequential biological samples over time.
Measuring patient response to cancer therapy, including chemotherapeutic agents, ionizing radiation therapy, or hormone ablation therapy, by observing changes in soluble c-Met ectodomain levels.
Diagnosing and monitoring various cancers, particularly urinary tract cancers such as bladder cancer, kidney cancer, and prostate cancer, as well as breast cancer and metastatic cancers.
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