Trials / Unknown

UnknownNCT05633342

Project CADENCE (CAncer Detected Early caN be CurEd)

Development and Validation of a Blood Test for Screening and Early Detection of Multiple Cancers Based on Circulating Cell-free Nucleic Acid Profiles - Project CADENCE (CAncer Detected Early caN be CurEd)

Status: Unknown
Phase: —
Study type: Observational
Enrollment: 15,000 (estimated)

Sponsor: MiRXES Pte Ltd · Industry
Sex: All
Age: 21 Years
Healthy volunteers: Accepted

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.

Detailed 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)

Conditions

Timeline

Start date: 2022-07-07
Primary completion: 2024-12-01
Completion: 2025-05-01
First posted: 2022-12-01
Last updated: 2023-03-20

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT05633342. Inclusion in this directory is not an endorsement.