Project CADENCE (CAncer Detected Early caN be CurEd) (CADENCE)

March 16, 2023 updated by: MiRXES Pte Ltd

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)

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.

Study Overview

Status

Recruiting

Conditions

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)

Study Type

Observational

Enrollment (Anticipated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To discover novel intracellular RNA and methylated DNA cancer biomarkers in fresh frozen tumor tissues.
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years
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).
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years
To discover and validate novel cell-free RNA and methylated cell-free DNA cancer biomarkers in the peripheral blood of cancer patients.
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years
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).
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years
To develop in vitro diagnostic assay(s) for the Multi-Cancer Screening Test (MCST) and if appropriate Single-Cancer Screening Tests (SCSTs).
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years
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.
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary outcome: • To explore the relationship between MCST/SCSTs with clinical outcomes based on the collection of longitudinal follow-up information from medical records.
Time Frame: through study completion, an average of 2.5 years
through study completion, an average of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MiRXES Pte Ltd

Investigators

  • Study Director: Cheng He, PhD, MiRXES Pte Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2022

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MX-011-219

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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