# Urine based circulating tumor DNA analysis

> **NIH NIH R37** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $432,494

## Abstract

ABSTRACT
Urine is an underappreciated source for systemic circulating tumor DNA in patients with non-genitourinary
cancers. Based on recent data suggesting that blood-based HPV DNA testing is useful for disease monitoring
in HPV positive oropharynx cancer patients, we identified non-metastatic HPV positive oropharyngeal cancer
patients as an excellent model system to examine the potential of urine-based transrenal DNA analysis. Our
preliminary data suggests that our newly developed urine-based HPV test could have biomarker performances
comparing favorably to blood-based HPV testing.
The specific objectives of this application are to establish that urine is a suitable source for HPV DNA in non-
metastatic HPV positive oropharynx cancer patients, and that at-home urine based molecular testing is feasible
for these patients. Specifically, we will compare sensitivity and specificity of pre-therapy urine-based HPV
testing to tissue gold standard testing in a cohort of newly diagnosed non-metastatic oropharyngeal cancer
patients. Recurrence detection lead time of urine-based HPV testing will be compared to clinical routine care in
the same cohort after curative intent treatment. Controls will include blood-based HPV testing, pharyngeal
swab-based HPV testing and blood based personalized ctDNA sequencing panel testing. Additional control
cohorts will include cervical and anal cancer patients as well as cancer-free patients with recently diagnosed
oncogenic HPV infections. Using in vivo fluorescence imaging techniques, we will generate fundamental
knowledge on renal handling of cell free DNA and determine the impact of chronic kidney disease and other
patient, disease and iatrogenic factors on cell free DNA excretion.

## Key facts

- **NIH application ID:** 10870078
- **Project number:** 5R37CA262238-04
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Tim Lautenschlaeger
- **Activity code:** R37 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $432,494
- **Award type:** 5
- **Project period:** 2021-07-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10870078

## Citation

> US National Institutes of Health, RePORTER application 10870078, Urine based circulating tumor DNA analysis (5R37CA262238-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10870078. Licensed CC0.

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