Study Results
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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UNKNOWN
15000 participants
OBSERVATIONAL
2022-07-07
2025-05-31
Brief Summary
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In this study, the investigators propose to develop and validate blood-based, multi-cancer screening tests through a multi-omics approach.
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Detailed Description
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* 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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Study Design
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COHORT
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
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
21 Years
ALL
Yes
Sponsors
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MiRXES Pte Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Cheng He, PhD
Role: STUDY_DIRECTOR
MiRXES Pte Ltd
Locations
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Biopollis, Helios
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MX-011-219
Identifier Type: -
Identifier Source: org_study_id
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