# Extracellular Vesicles in Small Cell Lung Cancer Early Detection

> **NIH NIH U01** · VIRGINIA COMMONWEALTH UNIVERSITY · 2020 · $492,386

## Abstract

PROJECT SUMMARY
Lung cancer is the leading cause of cancer deaths worldwide. While the implementation of lung cancer
screening for non-small cell lung cancer (NSCLC) subtypes has brought significant hope to this disease, very
limited options exist for the early detection of small cell lung cancer (SCLC) SCLC carries a 5-year survival rate
of only 7% and despite the development of novel targeted therapies and early detection for NSCLC, no such
advances have been achieved in SCLC. A gap in our current approach to lung cancer detection and treatment
has been that informative and reliable biomarkers for the detection and surveillance of lung cancer have
remained elusive. MicroRNAs (miRNAs) have emerged as viable biomarkers in body fluids thus, providing an
excellent means to achieve non-invasive assays for early cancer detection. Furthermore, miRNA expression in
circulation appears to be compartment specific. While the majority of miRNAs are intracellular, a significant
number of miRNAs have been observed outside of cells, including in various bodily fluids. The origin,
applications and potential functionality of RNAs in circulation are the sources of intriguing questions. Obtaining
a detailed RNA spectrum in plasma would shed some light on this matter. We have taken a multidisciplinary
approach to the investigation of circulating RNA transcripts that integrates expertise in miRNA biology,
nanoengineering, lung cancer and bioinformatics. We have developed a simple tethered Cationic Lipoplex
Nanoparticle (tCLN) biochip with pre-loaded molecular beacons (MBs) in the lipoplex nanoparticles as probes
to capture and detect targeted miRNAs and mRNAs in human plasma without any need of pre- or post-sample
treatment. We have successfully demonstrated the ability to assess both exosomal miRNAs and mRNAs using
both Next Generation Sequencing and our tCLN biochip in cohorts of control smokers and patients with early
stage NSCLC. Our primary objectives are to extend these novel findings by (1) Test and validate the utility of
measurement of ASCL1 and DLL3 in the early detection of SCLC in a retrospective and prospective study with
network samples (2) Develop A Panel of Comprehensive EV RNA Candidates using nest generation
sequencing and q-RT-PCR (3) Develop an optimized EV nanochip based RNA Classifier for early SCLC
detection and (4) Validate the optimized EV RNA Classifier by using the multiplex TLN array biochips in
independent, blinded case control studies at the OSU James Cancer Hospital and from the SCLC consortium.

## Key facts

- **NIH application ID:** 9878069
- **Project number:** 5U01CA213330-04
- **Recipient organization:** VIRGINIA COMMONWEALTH UNIVERSITY
- **Principal Investigator:** Ly James Lee
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $492,386
- **Award type:** 5
- **Project period:** 2017-03-20 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9878069

## Citation

> US National Institutes of Health, RePORTER application 9878069, Extracellular Vesicles in Small Cell Lung Cancer Early Detection (5U01CA213330-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9878069. Licensed CC0.

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