# Great Lakes New England Clinical Validation Center

> **NIH NIH U01** · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2022 · $803,955

## Abstract

The Great Lakes New England Clinical Validation Center (GLNE CVC), a Clinical Validation Consortium
component of the Early Detection Research Network (EDRN) is a highly collaborative group of investigators
whose aims to validate biomarkers for the early detection and risk assessment of cancers of the gastrointestinal
tract. In this fifth competitive application, the GLNE continues to test the overall hypothesis that a panel of
circulating and stool based biomarkers will increase the adherence to colorectal screening and in doing so reduce
mortality caused by colorectal cancers. Based on the rising incidence of colorectal cancer (CRC) among adults
age <50 in the US, and the low compliance and high mortality in underserved populations, increased emphasis
is placed on these populations. The GLNE also proposes to continue its ongoing support of EDRN discovery
priorities. We propose to address the following aims: (1) Primary Aim To expand and renew the archive of
appropriately preserved stool, serum, plasma, urine, tissue and DNA biospecimens to be used by EDRN
investigators for current and future validation and biomarker discovery research with expanded inclusion of
subjects with early-onset CRC and underserved populations. This will allow assessment of the utility of individual
stool-based, and serum-based biomarkers and biomarker panels for discriminating between individuals without
neoplasia (subjects both at average and higher risk for developing colon cancer), and those with colon cancer
or screen-relevant neoplasia (cancer plus advanced adenoma), and construction of panels of markers to
discriminate between these groups. (2) To perform validation trials of promising biomarkers discovered by EDRN
investigators, external collaborating institutions and collaborating EDRN industrial partners for the early detection
of colorectal neoplasia. In this context we propose to (a) to clinically validate (via a methods comparison study)
the performance of a point-of-care blood- based biomarker panel with the testing of serum/plasma samples
obtained in clinics serving low-income and underserved communities and (b) to clinically validate an established
4-plex stool protein panel for early diagnosis of CRC. (3) To follow prospectively subjects enrolled in an
established prospective Phase 2 validation trial to identify pre-diagnostic specimens which may be used to
develop predictive markers.

## Key facts

- **NIH application ID:** 10484455
- **Project number:** 2U01CA086400-21
- **Recipient organization:** UNIVERSITY OF TX MD ANDERSON CAN CTR
- **Principal Investigator:** ROBERT S BRESALIER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $803,955
- **Award type:** 2
- **Project period:** 2000-05-15 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10484455

## Citation

> US National Institutes of Health, RePORTER application 10484455, Great Lakes New England Clinical Validation Center (2U01CA086400-21). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10484455. Licensed CC0.

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