Ki-67 Protein Index for Leukemia Tumor Load Monitoring
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Solution Overview
Problem
Current methods for diagnosing and monitoring leukemia and lymphoma are limited by their reliance on biopsy samples, which provide localized information and may not accurately reflect the entire body's tumor load, and lack reproducibility.
Innovation Solution
The use of Ki-67 protein levels in acellular body fluid samples, such as plasma or serum, to diagnose, monitor, and predict the prognosis of leukemia and lymphoma, by comparing measured levels to predetermined cutoff values and calculating a Ki-67 index normalized to lymphocyte concentration, allowing for more comprehensive and reproducible assessments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If biopsy samples are used for diagnosis and monitoring, then localized information is obtained, but the results do not accurately reflect the entire body's tumor load and lack reproducibility
Solution Approach 1:
The invention extracts Ki-67 protein from acellular body fluid samples (plasma, serum, or urine) to serve as a diagnostic and monitoring marker. This extraction approach allows measurement of systemic tumor burden without requiring invasive biopsies, thereby improving both accuracy in reflecting overall tumor load and reproducibility of results across different sampling locations and time points.
2Loss of information
If Ki-67 protein levels in acellular body fluid are measured, then comprehensive information on tumor load is obtained, but the measurement and normalization process becomes more complex
Solution Approach 1:
The invention uses Ki-67 protein as an intermediary marker that reflects tumor cell proliferation activity in the bloodstream. By measuring this intermediary substance in easily obtainable acellular body fluids and normalizing to lymphocyte counts, the system comprehensively assesses tumor burden without requiring complex imaging or multiple biopsy sites, thus balancing information completeness with measurement simplicity.
Data Source
AI summary
The present invention provides methods and compositions for detection, diagnosis, prognosis, monitoring treatment and monitoring progression of cancer by detecting the level of Ki-67 protein in an individual.