# Noncoding RNA Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer

> **NIH NIH U01** · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · 2021 · $1,445,861

## Abstract

PROJECT SUMMARY: Pancreatic cancer is the fourth leading cause of adult cancer deaths in the U.S., and
will become the second leading cause of cancer-related deaths by 2030. The lack of reliable and cost-effective
assays impedes wide-spread pancreatic cancer diagnostics. Clearly, early diagnostic procedures will improve
the prognosis of patients with pancreatic ductal adenocarcinoma (PDAC), but will require novel methods of
development. MicroRNAs (miRNAs) are small noncoding RNAs that are implicated in the tumorigenesis of
every human cancer, including PDAC. Importantly, miRNAs are robust and resistant to degradation in tissues
and body fluids, making them ideal candidates as non-invasive biomarkers. The recent discovery of cancers
that actively excrete specific miRNAs in small vesicles, called “exosomes”, has brought additional enthusiasm
to the cancer biomarker arena. Previous attempts to define blood-based miRNA biomarkers that can
discriminate between non-invasive, early-stage and late-stage PDAC were insufficiently sensitive or specific
because of improperly designed cohorts and the narrow dynamic ranges of technologies used. Furthermore,
candidate markers were non-comprehensively selected, studies lacked important controls, and the cohorts
were insufficiently powered or validated, or did not represent the average risk population. These factors stifled
the discovery of miRNA biomarkers that could identify asymptomatic patients before metastatic disease had
developed, or distinguish early stage, radiographically occult PDAC from noninvasive pancreatic precancerous
neoplasms (PNs). In this proposal, innovative strategies including Next Generation Sequencing (NGS)-based
miRNA-Seq will be applied to the genome-wide and systematic discovery of comprehensive and highly specific
blood-based miRNAs by analyzing tissues and matching plasma that discern different stages of invasive PDAC
and PN. A novel and powerful new approach is being proposed to identify biomarkers with the highest
sensitivity and specificity, which will be validated in a prospective, large, well-characterized samples through
the following Specific Aims. Aim #1: Discover candidate cell-free and exosomal-miRNA biomarkers using
small RNA-Seq in matched tissue and plasma from patients with PDAC, PNs, pancreatitis and normal
pancreas. Aim #2: Develop a cell-free and exosomal-miRNA biomarker panel that distinguishes patients with
PDAC from those with PNs or pancreatitis. Aim #3: Clinically validate the optimized panel of non-invasive
miRNA biomarkers (identified in Aim #2) in prospective cohorts of patients with PDAC and PNs.
This project is innovative as it will use NGS-based miRNA-Sequencing for discovery of cell-free and exosomal
miRNA biomarkers in matched tissue and plasma samples, and validate these in multiple, well-characterized
cohorts of patients with PNs and PDAC vs. controls. If successful, this proposal will profoundly transform early-
detection of pancreatic cancer using a...

## Key facts

- **NIH application ID:** 10246989
- **Project number:** 5U01CA214254-05
- **Recipient organization:** BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
- **Principal Investigator:** Ajay Goel
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,445,861
- **Award type:** 5
- **Project period:** 2017-09-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10246989

## Citation

> US National Institutes of Health, RePORTER application 10246989, Noncoding RNA Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer (5U01CA214254-05). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10246989. Licensed CC0.

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