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Clinical Trial Summary

With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be dysregulated during disease progression. Combining the power of multi-omic cancer biomarkers, the investigators hypothesize that the sensitivity and specificity of MiRXES MCST can be significantly improved compared to existing multi-cancer diagnostic tests. In this study, the investigators propose to develop and validate blood-based, multi-cancer screening tests through a multi-omics approach.


Clinical Trial Description

This study consists of four (4) objectives: - Characterize intra-cellular multi-omic profiles of cancer and adjacent normal tissues to aid the selection of circulating cancer biomarkers. - Select and verify circulating multi-omic cancer biomarkers by characterizing the circulating multi-omic profiles of the peripheral blood of cancer patients, high-risk, increased-risk, and healthy controls, guided by tissue-based cancer omics profiles. - Develop multi-cancer screening in vitro diagnostic assay(s) based on the selected blood-borne circulating multi-omic cancer biomarker panel(s) and build algorithm(s) to distinguish cancer cases from control groups. - Clinically validate the performance (AUC, sensitivity, specificity) of the multi-cancer screening assay(s) and algorithm(s) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05633342
Study type Observational
Source MiRXES Pte Ltd
Contact Yvanka Gilliam, PharmD
Phone +6581146906
Email yvankagilliam@mirxes.com
Status Recruiting
Phase
Start date July 7, 2022
Completion date May 2025

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