# U-01 CONSORTIUM FOR THE STUDY OF CHRONIC PANCREATITIS,DIABETES AND PANCREATIC CANCER CLINICAL CENTERS

> **NIH NIH U01** · UNIVERSITY OF FLORIDA · 2022 · $455,662

## Abstract

The continuation of the CPDPC will require the completion of the acquisition of subjects and
biospecimens, and sufficient follow-up to determine clinically relevant outcomes. Future efforts
for which the CPDPC was formed include includes biomarker development and validation, drug
development or repurposing, and therapeutic trials. Biomarker development and validation is
needed for such purposes as early diagnosis (chronic pancreatitis and pancreatic cancer),
prognosis, risk stratification and precision therapy. A second clinical need is the development of
better therapies for the diabetes associated with pancreatic diseases, and better management
of the pancreatic diseases themselves. We propose one biomarker study for the next phase of
the CPDPC, a study of sarcopenia as a biomarker for worse outcome in patients with chronic
pancreatitis. We also propose 2 potential trials for the next phase of the CPDPC, one focused
on developing more effective therapy for pancreaticogenic (Type 3c) diabetes and one for a trial
assessing timing of surgical intervention in painful chronic pancreatitis:
 1. Finalize recruitment and follow-up of the PROCEED, DETECT, and NOD cohorts, and
 incorporate strategies to increase recruitment of NOD subjects. Recruitment, retention,
 and high quality data will need to be continued for all the cohorts. Recruitment into the
 NOD protocol has been most challenging. We will utilize the OneFlorida clinical data
 research network to identify partner health organizations within Florida to increase the
 pool of eligible study subjects in both NOD as well as future clinical trials.
 2. Characterize the prevalence, predictors, and impact of sarcopenia in patients with acute
 relapsing pancreatitis and chronic pancreatitis, and the interaction with coexistent
 diabetes; and establish strategies to identify and treat sarcopenia in these patients.
 While sarcopenia has been identified as a common consequence of pancreatic cancer,
 the prevalence of sarcopenia and clinical impact in patients with chronic pancreatitis is of
 equal clinical import.
 3. Implement a clinical trial within the CPDPC assessing the timing of surgical intervention
 in patients with painful chronic pancreatitis or relapsing pancreatitis. Pain is the most
 common symptom from chronic pancreatitis, the most common reason for intervention,
 and the most important detractor from quality of life. Medical, endoscopic, and surgical
 therapy are not highly effective, and the choice and timing of intervention for best
 outcomes is not known. A trial comparing outcomes from surgical therapy (drainage or
 resection) compared to endoscopic therapy in individuals with suitable anatomy who are
 not dependent on opioids and have not developed continuous pain is likely to identify
 more effective timing of therapy.
 4. Determine the most effective and safest management strategy for pancreaticogenic
 diabetes (Type 3c) in patients with chronic pancreatitis. These individuals have...

## Key facts

- **NIH application ID:** 10447175
- **Project number:** 5U01DK108320-08
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Kenneth Cusi
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $455,662
- **Award type:** 5
- **Project period:** 2015-09-28 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10447175

## Citation

> US National Institutes of Health, RePORTER application 10447175, U-01 CONSORTIUM FOR THE STUDY OF CHRONIC PANCREATITIS,DIABETES AND PANCREATIC CANCER CLINICAL CENTERS (5U01DK108320-08). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10447175. Licensed CC0.

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