DOI: 10.6084/m9.figshare.14604465
title: Metadata record for the article: Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population

description: <b>Summary</b><br> This metadata record provides details of the data supporting the claims of the related article: “Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population”. The related study aimed to interrogate a large real-world database of comprehensive genomic profiling data to describe the genomic landscape and prevalence of neurotrophic tropomyosin receptor kinase (NTRK) gene fusions. Subject of data: <i>Homo sapiens</i> Sample size: Data from 295,676 de-identified, consented-for-research cases between January 2013 and December 2019 from 75 different solid tumour types were profiled. Sample size for the clinical trials population was the efficacy-evaluable population, i.e., all patients who had received at least one dose of entrectinib and had at least 6 months of follow up. Recruitment: This is a secondary analysis of data from the clinical trials listed below. Full methods have been published previously in: https://doi.org/10.1016/s1470-2045(19)30691-6 Trial registration number: ALKA-372-001 [EudraCT 2012-000148-88], STARTRK-1 [NCT02097810], STARTRK-2 [NCT02568267] <b>Data access</b> The data were generated and analysed under the auspices of Roche, which is a member of the Vivli Center for global clinical research data. Data access conditions are described at https://vivli.org/ourmember/roche/. To request access to individual patient-level data from the clinical trials, first locate the clinical trial in Vivli (https://search.vivli.org/ requires sign up and log in) using the trial registration number (given above), then click the ‘Request Study’ button and follow the instructions. In the event that you cannot see a specific study in the Roche list, an Enquiry Form can be submitted to confirm the availability of the specific study. To request access to related clinical study documents (eg: protocols, CSR, safety reports), please use Roche’s Clinical study documents request form: https://www.roche.com/research_and_development/who_we_are_how_we_work/research_and_clinical_trials/our_commitment_to_data_sharing/clinical_study_documents_request_form.htm.Patient-level data which were derived from the Foundation Research dataset and used in the related study cannot be shared as they contain patient genomic information that, depending on the prevalence of the identified alterations, could be used to identify individuals. To maximise transparency and provide the most thorough information without compromising patients’ personal information, the authors have created a large number of supplementary files and made them openly available as part of this figshare data record. Data underlying Supplementary Figure 2 are in the file ‘data_underlying_supplementary_figure_2.xlsx’. Data underlying Supplementary Tables 1–4, 6–12, and 14 are in the file ‘FMI NTRK manuscript_Supplementary Tables_17May2021.xlsx’. <b>Corresponding author(s) for this study</b> Dr C. Benedikt Westphalen, Comprehensive Cancer Center Munich & Department of Medicine III, University Hospital, LMU Munich, Marchioninistr. 15, 81377, Munich, Germany. Tel: +49 (089) 4400-75250; E-mail: cwestpha@med.lmu.de <br> <b>Study approval </b> Approval was obtained from the Western Institutional Review Board (Protocol No. 20152817). Written consent was obtained to use the de-identified patient samples for research.<br>