Project CADENCE (CAncer Detected Early caN be CurEd)

Last updated: March 16, 2023
Sponsor: MiRXES Pte Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Ovarian Cancer

Breast Cancer

Treatment

N/A

Clinical Study ID

NCT05633342
MX-011-219
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Healthy average-risk cohort Individuals representing the general population whoself-declare to have no cancer history and have no indications suggestive of underlyingcancer development. Subjects will be recruited from a state-of-the-art population study. Increased-risk (genetic/familial) cohort Individuals carrying certain germline mutationsthat predispose the subjects to an increased risk of having cancer than the generalpopulation. Subjects will be recruited from Cancer Genetics Service (CGS). High-risk cohort Individuals diagnosed with diseases that have a high risk of progressingto cancer. Malignant cohort Individuals diagnosed with cancer. Wherever possible, samples for the 'Malignant group' should have a representation of each cancer stage.

Exclusion

Exclusion Criteria: Pregnant or lactating (self-declaration), unwilling or unable to provide signed informedconsent and has or had received chemotherapy or radiotherapy for cancer treatment and/orany other cancer-related treatment.

Study Design

Total Participants: 15000
Study Start date:
July 07, 2022
Estimated Completion Date:
May 31, 2025

Study 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)

Connect with a study center

  • Biopollis, Helios

    Singapore, 258710
    Singapore

    Active - Recruiting

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