Metadata record for the article: Genomic context of NTRK1/2/3 fusion-positive tumours from a large real-world population

Summary

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: Homo sapiens

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]

Data
access

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’.

Corresponding author(s) for this study

Dr
C. Benedikt Westphalen, Comprehensive Cancer Center Munich & Department of
Medicine III, University Hospital, LMU Munich, Marchioninistr. 15, 81377,
Munich, Germany. Tel: [phone]; E-mail: [e-mail]

Study approval

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.