# Analytic diagnosis methods for disease ruling

> **NIH NIH R01** · EMORY UNIVERSITY · 2024 · $346,124

## Abstract

PROJECT SUMMARY/ABSTRACT
Disease ruling, that is, ruling-out or ruling-in, is a main objective of cancer diagnosis to aid in medical decision
making. Taking prostate cancer as our primary example, treatment of intermediate and high risk, early stage
prostate cancer has shown survival beneﬁts, but not so for low risk cancer. Meanwhile, prostate cancer screen-
ing via prostate-speciﬁc antigen (PSA) testing has led to excess unnecessary prostate biopsies and over-detection
of low risk cancer. New strategies are urgently needed for diagnosing aggressive cancer, while avoiding un-
necessary prostate biopsies and over-treatment of indolent cancer. Ruling out or ruling in aggressive prostate
cancer at various clinical decision points in patient care are thus essential. However, the lack of a robust ana-
lytic framework and methodology for disease ruling is one major roadblock. To address this pressing analytic
need, this project will develop a novel performance metric directly tied to clinical utility so as to establish an
analytic paradigm for disease ruling. Furthermore, robust and efﬁcient statistical and computational methods
will be developed for the formulation and simultaneous performance estimation of multiplex diagnostic rules.
Five speciﬁc aims will be pursued. Aim 1 will focus on the conceptual development of the proposed analytic
paradigm as well as disease ruling methods with single predictors. Aim 2 considers disease ruling with multiple
predictors where these predictors are combined via a standard procedure, e.g., logistic regression. Aims 3 and 4
investigate multiplex disease ruling via empirical optimization in linear and Boolean classes, respectively. As
Aims 1–4 target either ruling-out or ruling-in, Aim 5 investigates simultaneous ruling-out and ruling-in. These
proposed analytic methods will be thoroughly investigated through rigorous asymptotic studies and extensive
simulations. They will be applied to a number of our prostate cancer biomarker studies, which motivated this
project, from the National Cancer Institute's Early Disease Research Network (EDRN). User-friendly computer
software will be made available to the research community. These proposed methods will facilitate more effective
and clinically relevant diagnostics research for cancers as well as other diseases.

## Key facts

- **NIH application ID:** 10882230
- **Project number:** 1R01CA283687-01A1
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** YIJIAN HUANG
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $346,124
- **Award type:** 1
- **Project period:** 2024-09-01 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10882230

## Citation

> US National Institutes of Health, RePORTER application 10882230, Analytic diagnosis methods for disease ruling (1R01CA283687-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10882230. Licensed CC0.

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