Methods for diagnosing and monitoring the progression of cancer by measuring soluble c-Met ectodomain
Inventors
Bottaro, Donald P. • Athauda, Gagani P. • Burgess, Teresa Lynn
Assignees
Amgen Inc • US Department of Health and Human Services
Publication Number
US-8617831-B2
Publication Date
2013-12-31
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 measuring c-Met levels in biological samples such as urine and blood to diagnose and monitor cancer. It is based on the discovery that tumor cells expressing c-Met shed more soluble c-Met ectodomain compared to normal cells, a process that intensifies with increasing malignancy. This shedding can be quantified before tumors become palpable and correlates directly with tumor volume, making it a reliable indicator of malignant potential and tumor burden.
The methods include diagnosing cancer, identifying patients at increased risk of developing cancer, monitoring cancer progression, and evaluating response to cancer therapy by measuring soluble c-Met ectodomain levels in patient samples. The measurements can be performed on biological fluids such as urine, plasma, or blood, and combinations thereof.
The background section outlines the challenge of the need for a sensitive, cost-efficient screening test for c-Met overexpression related to cancer diagnosis, staging, prognosis, and treatment efficacy. Existing knowledge recognizes c-Met as a receptor widely implicated in various cancers and involved in processes like cell growth, survival, and metastasis. The invention addresses this need by providing quantitative assays for soluble c-Met ectodomain as a practical biomarker for early detection and monitoring of cancer.
Claims Coverage
The patent contains multiple independent claims focused on methods of monitoring cancer status and measuring patient response to cancer therapy through soluble c-Met ectodomain concentrations.
Method of monitoring cancer status using soluble c-Met ectodomain concentrations
Determining soluble c-Met ectodomain concentration in a biological tissue of the same type at two different time points from the patient, and comparing these concentrations to assess whether the cancer has regressed, worsened, or remained stable.
Repeated monitoring of soluble c-Met ectodomain over multiple time points
Extending the method of monitoring cancer status by measuring soluble c-Met ectodomain concentrations in additional biological tissues of the same type at progressively later time points to track cancer progression or regression over time.
Method for measuring cancer therapy response via soluble c-Met ectodomain levels
Determining soluble c-Met ectodomain concentration in a biological tissue from the patient at two time points, comparing these values to assess if the patient has responded positively, negatively, or not at all to cancer therapy.
Inclusion of various cancer types relevant to c-Met monitoring
Application of the monitoring and therapy response methods to metastatic cancer, urinary tract cancers including kidney, renal, bladder, renal cell carcinoma, prostate cancer, and breast cancer.
Use of different cancer therapies in measuring response
The therapy response measurement methods include administration of anti-cancer drugs such as chemotherapeutic agents, ionizing radiation therapy, and hormone ablation therapy.
The independent claims cover methods of quantifying soluble c-Met ectodomain in biological tissues over time to monitor cancer status and response to therapies across a spectrum of cancers, primarily focusing on comparisons of concentrations in samples of the same tissue type at different time points to determine disease progression or regression.
Stated Advantages
Provides a reliable and practical indicator of malignant potential and overall tumor burden before tumors become palpable.
Enables early diagnosis and prognosis evaluation of cancer through sensitive measurement of soluble c-Met ectodomain in urine and blood samples.
Allows monitoring of cancer progression and assessment of patient response to cancer therapy.
Facilitates cost-efficient cancer screening and can be used for multiple cancer types including urinary tract and breast cancers.
Documented Applications
Diagnosing cancer in patients by measuring soluble c-Met ectodomain levels in biological samples like urine and blood.
Identifying patients having an increased risk of developing cancer through elevated c-Met ectodomain concentrations relative to control populations.
Monitoring the progression of cancer by comparing c-Met ectodomain levels in biological samples taken at different times.
Measuring response to cancer therapy by assessing changes in soluble c-Met ectodomain concentrations over time.
Screening for various cancers including bladder cancer, breast cancer, prostate cancer, kidney cancer, renal cancer, and renal cell carcinoma.
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