Machine Learning Biomarker Classification for FOLFOX Treatment

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Solution Overview

Problem

Current cancer treatment approaches are often 'one-size-fits-all,' leading to variable efficacy and the exhaustion of conventional therapies, as they rely on clinical observations and limited molecular testing.

Innovation Solution

Comprehensive molecular profiling is used to gather data from a patient's tumor, creating a unique molecular profile that aids in selecting individualized treatment regimens, independent of cancer type, stage, or location, and machine learning models are trained to predict treatment effectiveness based on biomarker signatures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If comprehensive molecular profiling and machine learning models are used to predict treatment effectiveness, then treatment selection accuracy is improved, but system complexity and cost increase

Engineering Contradiction:
Improvetreatment selection accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system segments the complex treatment selection process into distinct components: molecular profiling of tumor samples, extraction of biomarker signatures, training of multiple machine learning models on historical data, and aggregation of model predictions. This segmentation allows each component to be optimized independently while maintaining overall system accuracy.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces molecular biomarker signatures as intermediaries between the patient's tumor characteristics and the treatment selection decision. These biomarkers serve as measurable indicators that bridge the gap between complex biological data and clinically actionable treatment recommendations, reducing the complexity of direct treatment-patient matching.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If multiple machine learning models are used for classification, then prediction reliability is improved, but computational time and resources increase

Engineering Contradiction:
Improveprediction reliabilityVSAvoidcomputational time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent merges multiple machine learning model predictions through a voting mechanism that aggregates results from diverse algorithms (e.g., random forest, support vector machines, neural networks). This combination approach leverages the strengths of different models to improve overall prediction reliability while distributing computational workload across parallel processing tasks.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system performs preliminary training of multiple machine learning models on historical molecular profiling data and treatment outcomes before actual patient classification. This pre-training phase establishes baseline predictions and allows for model optimization, reducing the computational time required during actual clinical decision-making.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If molecular profiling data is gathered from tumor samples, then individualized treatment selection is improved, but testing cost and complexity increase

Engineering Contradiction:
Improveindividualized treatment selectionVSAvoidtesting complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The system extracts specific biomarker signatures from comprehensive molecular profiling data of tumor samples. Rather than analyzing all molecular characteristics, the patent identifies and focuses on key biomarkers that are most predictive of treatment response, reducing testing complexity while maintaining individualized treatment selection capability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent transforms complex molecular profiling data into standardized biomarker signature parameters that can be processed by machine learning models. This parameter transformation converts diverse molecular measurements into a consistent format, simplifying the testing and analysis process while preserving the ability to make individualized treatment recommendations.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS20250125034A1Classifying an entity for folfox treatment
Publication Date: 2025.04.17 CARIS MPI INC
  • US20250125034A1 patent drawing
  • US20250125034A1 patent drawing
  • US20250125034A1 patent drawing

AI summary

Comprehensive molecular profiling provides a wealth of data concerning the molecular status of patient samples. Such data can be compared to patient response to treatments to identify biomarker signatures that predict response or non-response to such treatments. This approach has been applied to identify biomarker signatures that strongly correlate with response of colorectal cancer patients to FOLFOX. Described herein are data structures, data processing, and machine learning models to predict effectiveness of a treatment for a disease or disorder of a subject having a particular set of biomarkers, as well as an exemplary application of such a model to precision medicine, e.g., to methods for selecting a treatment based on a molecular profile, e.g., a treatment comprising administration of 5-fluorouracil/leucovorin combined with oxaliplatin (FOLFOX) or with irinotecan (FOLFIRI).