Validation of Correlates of Risk of TB Disease in High Risk Populations (CORTIS-HR) Study: Public, subject-level RISK11 signature scores and metadata

The Validation of Correlates of Risk of TB Disease in High Risk Populations (CORTIS-HR) Study, a companion study of the CORTIS-01 Trial (ClinicalTrials.gov: NCT02735590), was conducted to test the diagnostic and prognostic performance of the RISK11 biomarker for tuberculosis (TB) disease in people living with HIV (PLHIV) in an ambulant community setting. The “CORTIS-HR pubdata.csv” is a public, subject-level dataset for the CORTIS-HR study containing key variables necessary to reconstruct the study findings.

A data dictionary is provided below. The “CORTIS-HR PCR data.csv” provides subject-level TaqMan qPCR probe raw CT (cycle threshold) gene expression data from the Fluidigm microfluidic 96.96 Gene Expression Integrated Fluidic Circuits (chips) with sample quality control (“SAMPLE_QC”) results. Analyses of the qPCR probe data are ongoing; the embargo on this data ends 1 July 2021 when the data will be available on ZivaHub. “CORTIS-HR Protocol Version 1.0.pdf” and “CORTIS-HR SAP Version 1.0.pdf” are the protocol and the statistical analysis plan for the study respectively and have been included for reference.