Project CADENCE (CAncer Detected Early caN be CurEd)

Breast Cancer Clinical Trial

— CADENCE  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05633342
• Other study ID #: MX-011-219
• Status: Recruiting
• Start date: July 7, 2022
• Est. completion date: May 2025

Study information

• Verified date: March 2023
• Source: MiRXES Pte Ltd
• Contact: Yvanka Gilliam, PharmD
• Phone: +6581146906
• Email: yvankagilliam[@]mirxes.com
• Is FDA regulated: No
• Study type: Observational

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Esophageal Cancer
• Gastric Cancer
• Liver Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer
• Thoracic Cancer

Locations

Country	Name	City	State
Singapore	Biopollis, Helios	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
MiRXES Pte Ltd

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To discover novel intracellular RNA and methylated DNA cancer biomarkers in fresh frozen tumor tissues.		through study completion, an average of 2.5 years
Primary	To select the best-performing multi-omic single-cancer, biomarker panels for each of the cancer types, and develop the corresponding Single-Cancer Early detection Algorithms (SCEAs).		through study completion, an average of 2.5 years
Primary	To discover and validate novel cell-free RNA and methylated cell-free DNA cancer biomarkers in the peripheral blood of cancer patients.		through study completion, an average of 2.5 years
Primary	To develop the best-performing multi-omic multi-cancer biomarker panel by integration and/or optimization of single-cancer panels and develop the corresponding Multi-Cancer Early detection Algorithm (MCEA).		through study completion, an average of 2.5 years
Primary	To develop in vitro diagnostic assay(s) for the Multi-Cancer Screening Test (MCST) and if appropriate Single-Cancer Screening Tests (SCSTs).		through study completion, an average of 2.5 years
Primary	To evaluate the clinical performance (AUC, sensitivity, specificity, tissue of origin) of the MCST and if appropriate SCSTs to discriminate cancer cases from control groups.		through study completion, an average of 2.5 years
Secondary	Secondary outcome: • To explore the relationship between MCST/SCSTs with clinical outcomes based on the collection of longitudinal follow-up information from medical records.		through study completion, an average of 2.5 years