Research evidence — not a medical device — not personalized medicine as a clinical product

Thesis #3 · working method manuscript · 20 September 2026

Disease Profiles for Complex Pathologies: A Gated Method for Systemic Personalized-Medicine Research Objects

Kelechi Emeka Ogbonna · Project Confluence · Vancouver citations · shipped schema 1.0.0 at 64ba76b

Scope. This page is a scholarly landing record for a method paper. It is not a patient chart, not clinical decision support, and not personalized medicine as a clinical product. Qualitative boards are not simulated patient benefit. See DISCLAIMER.md.

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Abstract

Personalized medicine is often described as if a molecular chart of a person would yield a dose. That leap is a product claim. Complex pathologies — triple-negative breast cancer with coupled metabolic and immune exclusion, glioblastoma with hypoxic and invasive niches, pancreatic ductal adenocarcinoma with a desmoplastic stromal barrier, and dormant or occult residual disease — do not become usable research objects by pasting a knowledge-graph page into an ordinary differential equation.

This thesis defines the Disease Profile as a versioned research object for systemic personalized-medicine research. Completing a four-question thinking laboratory (who is asking; which disease, not “cancer”; regime; where the system is stuck) exports a profile with observables, candidate mechanisms, an explicit non-parameter list, admitted hypotheses, Vancouver citations, and a fixed research-only disclaimer. Admission is gated:

Knowledge ≠ Evidence ≠ Mechanism ≠ Parameter ≠ Prediction

OnCo knowledge, OnCo confidence.probability, Idea maturity, and the legacy gene-to-parameter map must not enter Θ. Profiles feed confluence.profiles.HypothesisObject records aimed at named public datasets (example: data/hypotheses/tnbc_lactate_immune_exclusion.yaml → TCGA-BRCA). They do not write coefficients. The method cites CONFLUENCE adapter P0 (pull request #9), the merged Disease Profile pack (pull request #11), and Complexity Science CaseCards. Worked examples are qualitative boards, not outcomes.

Keywords

Disease Profile; research object; personalized-medicine research; thinking laboratory; knowledge gates; HypothesisObject; OnCo; CONFLUENCE; CaseCard; TNBC; glioblastoma; PDAC; dormancy; FAIR; identifiability; not CDS

Contents of the PDF

  1. Introduction — two meanings of personalized medicine; research objects versus charts
  2. Aims — shipped contract, four questions, gates, case pack, HypothesisObjects, P0 / CaseCard sit
  3. Methods — confluence/profiles/ + data/profiles/cases/; named public datasets
  4. Worked examples — qualitative boards for the four shipped pack JSON files
  5. Discussion — efficiency of adding a new complex disease without an ODE edit
  6. Limitations and future work
  7. Vancouver references (verified DOIs only) and the product-refusal disclaimer

Shipped contract (no parallel schema)

Pull request #11 is merged on main at 64ba76b. Thesis #3 cites confluence/profiles/, schemas/disease_profile.schema.json, and data/profiles/cases/. It does not propose a second contract and does not edit CancerODE.

Related artefacts (cited, not over-claimed)

Disclaimer

This document is not personalized medicine as a clinical product. Disease Profiles are computational research artefacts. They are not a medical device, not CDS, not a diagnosis, not a dose, and not a cure. Data from OnCo (onco.cc), CC BY-NC 4.0; commercial use needs a licence.

Canonical PDF: docs/manuscript/thesis_03_disease_profile_method.pdf · Evidence-site copy: evidence/papers/thesis_03_disease_profile_method.pdf · Sitemap fragment: sitemap-thesis03.xml