# Core C - Clinical Research

> **NIH NIH P50** · UNIVERSITY OF IOWA · 2021 · $64,375

## Abstract

The Iowa Neuroendocrine Tumor SPORE Clinical Research Core (CRC) has, as its primary goal, to enable 
each project to bring the fruit of its scientific research to a clinical end point that will benefit patients both 
proximally and in the future. The Clinical Research Core is the direct translational link between research 
projects and clinical research emanating from these projects. This Core is directed by Thomas M. O'Dorisio, 
MD, with Daniel Vaena, MD, and Terry Braun, PhD, as co-directors; these directors are all members of the 
Holden Comprehensive Cancer Center. The specific aims of this Core are to: 
1) Continue to consent and enroll patients into the Iowa Neuroendocrine Tumor Registry and to 
 further develop the Iowa Neuroendocrine Tumor Database 
2) Coordinate and perform SPORE clinical trials protocols. The CRC will provide a critical link 
 between clinical research and the projects, cores, and developmental research projects; 
3) Review validity of and coordinate incorporation of new genetic, pathologic, and imaging tests, 
developed by Projects, into new clinical trials. 
Aim 1. The CRC obtains consent from newly diagnosed and referred patients with NETs, abstracts and enters 
clinical and epidemiologic data into the Neuroendocrine Tumor Database (REDCap), and systematically 
manages and treats patients through death. Tumor tissue and peripheral blood, serum, cells, DNA, and RNA 
are prospectively collected, stored and tracked in LabMatrix" by the Biospecimens Core for linkage to the 
database. This provides integrated and centralized access to SPORE investigators for NET research projects. 
The Iowa Neuroendocrine Tumor Clinic and Registry were established by Dr. O'Dorisio in 2000 and over 1300 
subjects (and family members) with NETs have been consented to this Registry. Aim 1 goals are to continue to 
recruit new patients to participate in the Registry and to continually maintain, update, and upgrade the 
databases that support the Registry. Patient data from each visit is entered regularly. 
Aim 2. Iowa SPORE investigators have been active in design and conduct of both investigator-initiated and 
NCI cooperative group trials for patients with NETs. These trials have encompassed imaging and dosimetry 
trials, therapeutic trials of new targeted biologicals and peptide receptor radionuclide therapy (PRRT); and the 
only Phase I trial of PRRT for children and adolescents. Key functions of the CRC in Aim 2 are to coordinate 
the development of clinical trials, assist in patient accrual, manage IRB consents and amendments for 
protocols, report adverse events to appropriate agencies, and provide comprehensive quality control (e.g. 
monitor for protocol deviations & clinical trial data performance). 
Aim 3. As suggested by reviewers, the CRC will facilitate incorporation of recent scientific SPORE advances 
into SPORE clinical trials. Projects 1, 2, 3, and 4 are poised to develop new imaging agents, genetic tests, and 
immunohistoche...

## Key facts

- **NIH application ID:** 10487599
- **Project number:** 3P50CA174521-05S3
- **Recipient organization:** UNIVERSITY OF IOWA
- **Principal Investigator:** Thomas odorisio
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $64,375
- **Award type:** 3
- **Project period:** 2015-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10487599

## Citation

> US National Institutes of Health, RePORTER application 10487599, Core C - Clinical Research (3P50CA174521-05S3). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10487599. Licensed CC0.

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