Project CADENCE (CAncer Detected Early caN be CurEd)

MiRXES

Status: Enrolling

Conditions: Breast Cancer; Esophageal Cancer; Gastric Cancer; Ovarian Cancer; Prostate Cancer; Liver Cancer; Thoracic Cancer; Pancreatic Cancer; Colorectal Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT05633342

MX-011-219

Details and patient eligibility

About

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.

Full 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)

Enrollment: 15,000 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

15,000 participants in 4 patient groups

Healthy average-risk cohort

Description:

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

Description:

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

Description:

Individuals diagnosed with diseases that have a high risk of progressing to cancer.

Malignant cohort

Description:

Individuals diagnosed with cancer.