# Project 3 : Clinical correlates and diagnostics in ME/CFS

> **NIH NIH U54** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2021 · $163,664

## Abstract

Project 3
Abstract
Despite recent progress in establishing clinical criteria for ME/CFS, diagnosis is delayed in many patients,
largely due to an absence of objective clinical and laboratory tests for disease. An additional challenge for
patients and clinicians alike is that the onset and course of ME/CFS are variable, as are comorbidities. The
implications of variability are myriad and include potential for differences in pathways to illness, prognosis, and
management. This project will lay the foundation for resolving diagnostic and prognostic uncertainty,
distinguishing sub-types, enabling insights into pathogenesis, and facilitating management of illness through
pursuit of three specific aims. In Aim 1, we will establish a hub for state-of-the-art translational research based
on the CfS for ME/CFS clinical network. The network will be fully committed to the NINDS Common Data
Elements project and to collection of survey data and biological samples needed for rigorous clinical research.
We will also design a mobile app, myME/CFS, to help patients and physicians acquire valuable longitudinal
data and personally and clinically manage the illness. In Aim 2, we will mine existing databases to identify
clinical sub-types that differ in presentation, course, comorbidities, family medical history, or other features. In
Aim 3, we will assess the clinical utility of a simple office-based test for autonomic dysfunction, the Lean Test.
We will also assess the impact of the Lean Test and an Exercise Tolerance Test on plasma metabolomics and
PBMC transcriptomics, thereby integrating this clinical research project with the two basic science projects in
the CfS for ME/CFS.

## Key facts

- **NIH application ID:** 10246408
- **Project number:** 5U54AI138370-05
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Anthony L Komaroff
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $163,664
- **Award type:** 5
- **Project period:** 2017-09-22 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10246408

## Citation

> US National Institutes of Health, RePORTER application 10246408, Project 3 : Clinical correlates and diagnostics in ME/CFS (5U54AI138370-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10246408. Licensed CC0.

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