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 immunohistochemistry panels. The CRC will guide and assist investigators in obtaining FDA approval for new agents and tests. CRC will then aide in incorporation of FDA approved advances into clinical practice.
Patients with neuroendocrine tumors (NETs) have few opportunities to participate in clinical trials due to the scarcity of NCI sponsored, investigator-initiated or cooperative group trials for these rare malignancies. Industry-supported clinical trials are also limited because this small patient population is not likely to return a large profit. The Iowa NET SPORE seeks to provide this opportunity to patients through a Clinical Research Core with a robust program of clinical trials encompassing diagnosis, therapy, symptom control, and extended high quality of life. The coordinated NET database in REDCap and associated specimen database in LabMatrix' will be shared widely, enabling other institutions to join efforts or establish their own database.
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