# Core B. Clinical & Biomarkers Core

> **NIH NIH P01** · UNIVERSITY OF MINNESOTA · 2024 · $656,005

## Abstract

ABSTRACT
The Clinical and Biomarkers Core is critical for the studies in this program project renewal proposal. The Core
will run clinical trials to collect biological samples and will carry out analyses of tobacco constituent biomarkers.
The Clinical Trial component of this Core includes trained personnel with clinical research and implementation
expertise that will be applied to conduct the clinical trials proposed in Projects 2 and 4. Both trials include the
use of stable isotope-labeled constituents. Project 2 will use oral administration of [pyridyl-D4]-nicotine to develop
a CYP2A6 genetic score that will allow to predict nicotine metabolism in smokers. This study will recruit 400
smokers (Native Hawaiians, Japanese Americans, Whites, and African Americans) in Hawaii and Minnesota.
Project 4 will administer [D10]phenanthrene and [13C18]linoleic acid to 50 never smokers and 50 formers smokers,
to investigate the potential contribution of metabolic and inflammatory pathways to the elevated risk for lung
cancer in former smokers. The Biomarkers component of the Core will analyze a panel of biomarkers of exposure
and effect. These will include total nicotine equivalents, cotinine, total 4-(methylnitrosamino)-1-(3-pyridyl)-1-
butanol, phenanthrene tetraol, and mercapturic acids of acrolein, crotonaldehyde, and propylene oxide, and
urinary cadmium (Cd) in urine samples collected in clinical trials. Plasma nicotine metabolite ratio will be also
measured. Results of these analyses will be used by Projects 2, 3, and 4. In addition, biomarkers of potential
harm (urinary and blood-based biomarkers relevant to oxidative stress and inflammation) will be measured for
Projects 3 and 4. The Core will also assess urinary Cd in 1000 samples from Project 1. The biological samples
and biomarker results generated by this Core will be used by all projects.

## Key facts

- **NIH application ID:** 10923844
- **Project number:** 5P01CA138338-13
- **Recipient organization:** UNIVERSITY OF MINNESOTA
- **Principal Investigator:** DOROTHY K HATSUKAMI
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $656,005
- **Award type:** 5
- **Project period:** 2009-12-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10923844

## Citation

> US National Institutes of Health, RePORTER application 10923844, Core B. Clinical & Biomarkers Core (5P01CA138338-13). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10923844. Licensed CC0.

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