Thoracic CancerCADENCENCT05633342
Project CADENCE (CAncer Detected Early caN be CurEd)
An observational study of Thoracic Cancer and Ovarian Cancer, run by MiRXES Pte Ltd at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Cancer, Ovarian Cancer, Liver Cancer
- How many people
- 15,000 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Jul 2022to May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Biopollis, Helios
Singapore, 258710
Cheng He, PhD, chenghe@mirxes.com
About this study
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)
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.
Read the 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)
- Conditions
- Thoracic Cancer, Ovarian Cancer, Liver Cancer, Prostate Cancer, Gastric Cancer, Colorectal Cancer
- Keywords
- MCED, Diagnostic Tests, MiRNA, CfDNA, CtDNA
- Medical subject headings
- Ovarian Neoplasms, Liver Neoplasms, Prostatic Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Breast Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To discover novel intracellular RNA and methylated DNA cancer biomarkers in fresh frozen tumor tissues.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: through study completion, an average of 2.5 years
Secondary outcomes (1)
Secondary outcome: • To explore the relationship between MCST/SCSTs with clinical outcomes based on the collection of longitudinal follow-up information from medical records.
Measured: through study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start7 Jul 2022
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiRXES Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng He, PhD, Study director, MiRXES Pte Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633342
- Sponsor's protocol ID
- MX-011-219
- Acronym
- CADENCE
- Status last verified
- Mar 2023
- First submitted
- 27 Oct 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05633342
- Acronym / sponsor ID
- CADENCE / MX-011-219
- Conditions
- Thoracic Cancer, Ovarian Cancer, Liver Cancer, Prostate Cancer, Gastric Cancer, Colorectal Cancer
- Keywords
- MCED, Diagnostic Tests, MiRNA, CfDNA, CtDNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- MiRXES Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
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
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng He, PhD study director
MiRXES Pte Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Cancer and Ovarian Cancer, run by MiRXES Pte Ltd at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yvanka Gilliam, PharmD (+6581146906, yvankagilliam@mirxes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.