Project CADENCE (CAncer Detected Early caN be CurEd)

NCT ID: NCT05633342

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-07

Study Completion Date

2025-05-31

Brief Summary

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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

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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)

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

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).

No interventions assigned to this group

High-risk cohort

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

No interventions assigned to this group

Malignant cohort

Individuals diagnosed with cancer.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MiRXES Pte Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cheng He, PhD

Role: STUDY_DIRECTOR

MiRXES Pte Ltd

Locations

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Biopollis, Helios

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Yvanka Gilliam, PharmD

Role: CONTACT

+6581146906

Facility Contacts

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Cheng He, PhD

Role: primary

Other Identifiers

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MX-011-219

Identifier Type: -

Identifier Source: org_study_id

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