# Clinical Trail 1

> **NIH NIH U54** · CINCINNATI CHILDRENS HOSP MED CTR · 2020 · $105,244

## Abstract

Project Summary (Clinical Research Project: OMEGA2)
Eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), eosinophilic gastroenteritis (EGE), and eosinophilic
colitis (EC) are four distinct and rare diseases that have no FDA-approved treatments. These diseases are often
collectively referred as eosinophilic gastrointestinal diseases (EGIDs). Our understanding of the pathogenesis
of EGIDs has many gaps that include identification of predictors and biomarkers of longitudinal disease
trajectory, understanding the molecular mechanisms and pathogenesis of these diseases, and defining
relationships between transcriptional profiles and clinical phenotypes. The current standard of care (SOC) is
repeated endoscopy with biopsy, and it is unclear whether biomarkers and patient-reported outcomes (PROs)
can accurately function as surrogates for tissue histology. In the first cycle of the Consortium Eosinophilic
Gastrointesinal Disease Researchers (CEGIR1), the longitudinal trial Outcome Measures for EGIDs across Ages
(OMEGA1) filled important gaps in our knowledge. We identified relationships between PROs in children and
their parents and the association of clinical outcome measures (COMs), including symptoms, endoscopy score,
and quality of life (QOL) metrics, with histologic and molecular disease activity, focused on EoE. CEGIR
elucidated distinct EoE endotypes and histologic and molecular commonalities and differences of EGIDs. In this
second CEGIR cycle (CEGIR2), OMEGA2 proposes the overarching hypothesis that COMs and molecular
biomarkers will associate with histologic features to allow accurate longitudinal phenotypic and clinical profiling
of EGID patient populations. OMEGA2 will assess key issues for clinical trial readiness in EGIDs. Specifically,
we aim to understand the COMs and transcriptome profiles that best reflect histologic disease courses to define
and refine diagnostic criteria and outcome metrics for clinical trials. In Aim 1, we will determine the association
between COMs and longitudinal disease courses. Using the existing and growing population of prospectively
enrolled EGID patients, we will test the hypothesis that COMs, including PROs and endoscopic severity metrics,
longitudinally correlate with histologic findings. We will determine whether COMs change over time and
treatments and whether they correlate with EGID histology. In Aim 2, we will determine the association of EGID
molecular profiles with phenotypes and outcomes. We will test the hypothesis that gastrointestinal mRNA
transcript signatures longitudinally associate with clinical and histologic phenotypes, COMs, and treatment
outcomes. We will determine whether diagnostic EG, EGE, and EC transcript panels predict treatment response
and/or change with treatment. In Aim 3, we will establish diagnostic criteria and guidelines for EG, EGE, and EC
using the COMs, endoscopic, histologic, and molecular data generated in OMEGA2 to conduct a formal
consensus and guideline proc...

## Key facts

- **NIH application ID:** 10019469
- **Project number:** 5U54AI117804-07
- **Recipient organization:** CINCINNATI CHILDRENS HOSP MED CTR
- **Principal Investigator:** GLENN T FURUTA
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $105,244
- **Award type:** 5
- **Project period:** 2014-08-15 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10019469

## Citation

> US National Institutes of Health, RePORTER application 10019469, Clinical Trail 1 (5U54AI117804-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10019469. Licensed CC0.

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