Core B: Clinical

University Of Iowa, Iowa City IA

Investigators

Abstract

Clinical Core – Summary The overarching goal of our Clinical Core is to serve as a bidirectional link between patients with neuroendocrine neoplasms (NEN) and advances in diagnosis, treatment, long-term care and, ultimately, disease prevention. Toward this end, we continue to recruit new patients to the IRB-approved Iowa NET Registry (currently over 2,400 subjects). Participation in the Registry includes permission to collect medical records both prospectively and retrospectively; it allows the use of biopsy or surgically resected NETs to be used in studies including organoid culture, genetic and proteomic analysis, immunohistochemistry and tissue microarray analysis. Registry Consent also allows subjects to be directly contacted if a clinical trial is being developed for which the patient might qualify. Clinical Core specific aims for the next five years are as follows: AIM 1: Continue to enroll patients into the Iowa NET Registry and enhance the Iowa NET database. This increases patient access to, and participation in, clinical trials. AIM 2: Support SPORE investigators in design, initiation, and conduct of SPORE clinical trials. The Clinical Core will advise on trial design, and provide coordinator and regulatory support. AIM 3: Incorporate pathologic, imaging and genetic tests developed by projects into clinical trials. The Clinical Core will facilitate incorporation of potential new biomarkers into future SPORE clinical trials. AIM 4: Establish a multicenter database of de-identified subjects to facilitate NET population science. Using the Iowa NET database dictionary and a central Iowa IRB, five clinical centers will develop a de- identified database of over 7,000 NET patients. Expected outcomes of this Clinical Core application are: 1. More efficient recruitment into NET clinical trials nationally and internationally. 2. Provision of high-quality specimens to the Biospecimens Core. 3. Specialized support for investigator-initiated trials. 4. De-identified database for epidemiology and population science research in NETs. IMPACT: By enhancing the ability of investigators to pursue translational and population science research, and by improving the access of patients to these studies, the Clinical Core will support progress towards improved length and quality of life for patients with NEN.