Abstract 5246: Conceptualization of core clinico-molecular variables for registries enrolling patients diagnosed with a solid tumor and profiled with next-generation sequencing (NGS)

Abstract In precision oncology, tailored treatment decisions are largely driven by genomic alterations in a patient’s tumor. To support epidemiological research, we initiated a registry that enrolls patients diagnosed with a solid tumor and profiled with NGS. Collecting and standardizing variables of interest across the patient journey is critical for data harmonization and understanding clinical relevance. We propose a framework for identifying core variables most critical for solid tumor-based, real-world data studies and registries in precision oncology. A patient representative and panel of experts in NGS, oncology, epidemiology, bioinformatics, molecular tumor boards, clinical coordination, and molecular pathology was assembled to compile a draft variables list. To reduce the burden of data collection and missingness, the variables were categorized by decreasing importance and reconciled with draft European Medicines Agency guidelines at the time of writing (final guidelines released October 26, 2021) on registry-based studies. If applicable, internationally harmonized coding dictionaries were used to standardize the variables. The variable list was created to: describe a patient’s cancer history and journey effectively; allow conduct of comparative effectiveness studies and comparisons with clinical trials; and represent key risk factors or important confounders for prognosis or statistical analysis adjustments. The draft list comprised ~500 variables and was reconciled to ~150; highest priority was given to patient information (e.g. consent, demographics, risk and prognostic factors, dates of cancer-related events), NGS test results (e.g. actionable alterations, genomic signatures), cancer details (e.g. disease ontology, staging, metastases), and therapy details/outcomes (e.g. treatment information, response, progression, death). Variables with moderate to lower priority comprised NGS (e.g. technical, quality criteria), familial cancer history, adherence to molecular tumor board recommendations, and primary cause of death. This list provides viable guidance for conducting research- and regulatory-grade real-world data-based precision oncology studies, and facilitating standardized data collection and thus pooling from various datasets. Citation Format: Rodrigo Dienstmann, Clare Turnbull, Allan Hackshaw, Jean-Yves Blay, Maud Kamal, Nicolas Servant, Jan Geissler, David Tamborero, Janick Weberpals, Simon Fear, Camille Perret, Laura Perez, Martina von Meyenn, Christophe Le Tourneau. Conceptualization of core clinico-molecular variables for registries enrolling patients diagnosed with a solid tumor and profiled with next-generation sequencing (NGS) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5246.