Project CADENCE (CAncer Detected Early caN be CurEd)

Trial Title: Project CADENCE (CAncer Detected Early caN be CurEd)

NCT ID: NCT05633342

Condition: Thoracic Cancer
Ovarian Cancer
Liver Cancer
Prostate Cancer
Gastric Cancer
Colorectal Cancer
Breast Cancer
Esophageal Cancer
Pancreatic Cancer

Conditions: Keywords:
MCED
Diagnostic Tests
MiRNA
CfDNA
CtDNA

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Other

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)

Criteria for eligibility:

Study pop:
This study will be carried out in 4 phases, namely Phase 1A, 1B, 1C, and 1D. Phase 1A and 1B will be carried out in parallel. Upon the completion of Phase 1A and 1B, Phase 1C will be initiated, followed by Phase 1D, which is the final phase of this study. All four phases involve participant recruitment (except Phase 1A), sample and data collection, and sample data analysis. Subjects recruited for CADENCE will be divided into four groups: (1) Healthy average-risk (2) Increased-risk (3) High-risk and (4) Malignant.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: Healthy average-risk cohort Individuals representing the general population who self-declare to have no cancer history and have no indications suggestive of underlying cancer development. Subjects will be recruited from a state-of-the-art population study. Increased-risk (genetic/familial) cohort Individuals carrying certain germline mutations that predispose the subjects to an increased risk of having cancer than the general population. Subjects will be recruited from Cancer Genetics Service (CGS). High-risk cohort Individuals diagnosed with diseases that have a high risk of progressing to cancer. Malignant cohort Individuals diagnosed with cancer. Wherever possible, samples for the 'Malignant group' should have a representation of each cancer stage. Exclusion Criteria: Pregnant or lactating (self-declaration), unwilling or unable to provide signed informed consent and has or had received chemotherapy or radiotherapy for cancer treatment and/or any other cancer-related treatment.

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Biopollis, Helios

Address:
City: Singapore
Zip: 258710
Country: Singapore

Status: Recruiting

Contact:
Last name: Cheng He, PhD
Email: chenghe@mirxes.com

Start date: July 7, 2022

Completion date: May 2025

Lead sponsor:
Agency: MiRXES Pte Ltd
Agency class: Industry

Source: MiRXES Pte Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05633342