Specimen and Data Core

Summary - Specimen and Data Core The proposed Specimen & Data Core will serve several central roles within this highly integrated Program Project: 1) it will consent and enroll all Merkel cell carcinoma (MCC) patients into our longitudinal research study; 2) it will acquire, process, and store all patient biospecimens (blood, fresh and archival tumor tissue, stool) and distribute them to the relevant Projects and the Immunopathology Core; and 3) it will obtain patient clinical data over time, and store research-derived patient results, annotating the samples with corresponding disease status. The proposed Core will expand both our existing MCC Specimen Repository that has over 40,000 individual specimens from more than 1,850 patients (as of May 2024) and our Relational Database that annotates those samples and patient demographics using approximately 300 data fields including clinical treatments, disease status, and response data, as well as research laboratory results. An essential role for the Specimen and Data Core will be to acquire tumor samples from patients before and after PD-1 checkpoint blockade therapy. Obtaining such tissues is complex and laborious but also essential for understanding the basis of response and non-response to these important new immune therapies. A recent expansion of our relational database involves the addition of over 30 fields to capture new immunotherapy-related results and experimental data that will be useful for the Projects as well as for the Immunopathology Core and the Bioinformatics and Biostatistics Core. The Specimen and Data Core will also track MCPyV oncoprotein antibody titers to assist in a) detecting early disease recurrence, b) understanding how to use this test in patients undergoing PD-1 checkpoint blockade therapy, and c) supporting Project 3 in understanding the biological basis of why these antibodies are associated with better outcomes, despite the fact that an antibody to an intracellular protein cannot directly contribute to tumor cell killing. This Core will also assess how best to use the new ctDNA test for measuring tumor burden and for predicting recurrences in MCC patients. Finally, the Specimen & Data Core will leverage these precious resources by sharing samples and data with the broader MCC and scientific communities through collaborative studies that have proven extremely productive, with 46 publications since our initial P01 grant submission in 2018 that have made use of repository specimens and data. Six of those publications were led by investigators outside of Seattle and not integral to this P01.