# BCM/TCH CHOLESTATIC LIVER DISEASE CONSORTIUM

> **NIH NIH U01** · BAYLOR COLLEGE OF MEDICINE · 2020 · $255,000

## Abstract

Abstract
There is a pressing and strong unmet need to develop noninvasive biomarkers of advancing
fibrosis and disease severity in pediatric liver disease. This is particularly important for cholestatic
disorders like biliary atresia, where the pace of development of fibrosis is remarkable. Current
measures are able with varying degrees of precision to distinguish advanced fibrosis/cirrhosis
from minimal to no fibrosis. Unfortunately, they are not able to differentiate intermediate stages
of fibrosis, nor are they reproducible enough for use as endpoints in the evaluation of investigation
products on liver disease progression. The field of noninvasive testing of hepatic disease, which
is complex and unresolved in the liver disease of adults, is especially difficult in pediatrics. Given
the invasive nature of liver biopsy most studies of biomarkers in pediatrics cannot be securely
associated with histologic measures of fibrosis. The patterns of fibrosis in pediatric liver disease
are distinct from diseases in adults. Preliminary analysis of the baseline FibroScan in Pediatric
Cholestatic Liver Disease (FORCE -NCT 02922751) study performed by ChiLDReN supports the
concept that fibrosis is distinct in biliary atresia, α-1 antitrypsin deficiency and Alagille syndrome.
A paradigm shift in the development of noninvasive markers of pediatric liver disease is
warranted. The shift should include unbiased nontargeted approaches to the identification of
biomarkers and innovative correlation with reproducible parameters of liver disease progression.
The current proposal seeks to leverage the discovery features of the protein-capture slow off-rate
modified aptamer reagents that are part of SOMAscan assay developed by SomaLogic in the
context of the FORCE study. Plasma samples from 255 FORCE participants will be analyzed
using the SOMAscan. Robust analytical techniques will be used to assess the correlation of
individual and combinations of plasma proteins with clinical characteristics, laboratory parameters
and biomarker indices. This analysis will lead to the identification of a unique set of proteins that
associate with features of advancing liver disease, like liver stiffness, platelet count, albumin and
growth parameters. These findings have a very high probability of accelerating fundamental
advances in our noninvasive assessment and understanding of pediatric cholestatic liver disease.

## Key facts

- **NIH application ID:** 10215815
- **Project number:** 3U01DK103149-07S1
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** BENJAMIN L SHNEIDER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $255,000
- **Award type:** 3
- **Project period:** 2014-09-10 → 2021-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10215815

## Citation

> US National Institutes of Health, RePORTER application 10215815, BCM/TCH CHOLESTATIC LIVER DISEASE CONSORTIUM (3U01DK103149-07S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10215815. Licensed CC0.

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