Diagnosis of Cancer of Various OrgansNCT03869814
Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
An observational study of Diagnosis of Cancer of Various Organs, run by ClearNote Health at 1 site in United States.
Trial summary
ClearNote Health is developing a test from whole blood for the early detection of multiple cancers. The goal of this study is to employ genomics, epigenomics and proteomics methodology for the detection of cancer signal in the blood of subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnosis of Cancer of Various Organs
- What is being tested?
- Blood Draw
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2018to 13 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Both study groups enrolled at medical centers across the United States
Who may be able to join
- Subjects must be between 21-80 years of age at the time of enrollment
- Patient fully consented
- Cancer diagnosis OR high clinical suspicion for cancer, based on the participating site's and practitioner's standards of care (SOC)
- No previous history of cancer and treatment naïve at time of enrollment
Who cannot join
- Age < 21 OR > 80 years of age
- Any prior cancer diagnosis with or without treatment (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment)
- Receipt of any cancer therapy including chemotherapy, radiation, palliative radiation, hormonal or naturopathic therapies
- In situ carcinoma without an invasive component
- Any surgery requiring general anesthesia within 2 months of collection. Anesthesia used in procedures such as colonoscopy and EBUS is acceptable.
- Receipt of systemic immunomodulation therapy within past 12 months
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- Currently pregnant, or pregnancy within last 12 months
- Organ transplantation
- Received dialysis
- Blood transfusion within 1 month
- Known HIV/AIDs, Hepatitis A, D, or E, TB, any kind of prion disorder (e.g., CJD) or other infectious pathogens currently present or present in past 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ClearNote Health, Inc.
San Diego, California, 92121
Melissa Peters, MA, PMP, CCRC, 833-258-7827, mpeters@clearnotehealth.com
About this study
ClearNote Health is developing a test from whole blood for the early detection of multiple cancers. The goal of this study is to employ genomics, epigenomics and proteomics methodology for the detection of cancer signal in the blood of subjects with solid tumors.
Read the detailed description
Epigenomic changes in cancer cells can provide a rich source of biomarker signals for the detection of disease. As cancer cells manifest their epigenomic changes in blood due to cell death, DNA and protein molecules can be probed using specific molecular analytic approaches. ClearNote Health employs epigenomic technologies to measure dynamic changes in DNA demethylation events via direct measurement of 5-hydroxymethyl-cytosine residues in cfDNA. Companion assays are also run to provide information on cfDNA digestion patterns and protein-based changes in plasma. This information, combined in a machine learning framework, enable the provision of prediction models that report on the presence of cancer and the determination of the tissue of tumor origin. This study will build predictive models and test performance of these models to detect the presence of cancer and tissue of origin in several cancer type by using a matched case-control study design.
- Conditions
- Diagnosis of Cancer of Various Organs
- Being tested
- Blood Draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
Blood Draw
| Study group | Role | What they receive |
|---|---|---|
| Non-cancer | 10,000 asymptomatic individuals without prior history of cancer Receives: Other: Blood Draw | |
| Cancer | 10,000 individuals with confirmed malignancy Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cancer signal in the cancer cohort
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals in plasma from non-cancer controls
Measured: Baseline
Detection of tissue of origin signal in the cancer cohort
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals from non-cancer controls
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start5 Apr 2018
- Primary completion13 Jun 2029 (estimated)
- Study completion13 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosis of Cancer of Various OrgansStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClearNote Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Levy, Ph.D., Study director, ClearNote Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869814
- Sponsor's protocol ID
- MT1410
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2019
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
- ClinicalTrials.gov ID
- NCT03869814
- Acronym / sponsor ID
- MT1410
- Conditions
- Diagnosis of Cancer of Various Organs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- ClearNote HealthIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 13 Jun 2029 (estimated)
- Study completion
- 13 Sep 2029 (estimated)
- First posted
- 11 Mar 2019 (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.
ClearNote Health is developing a test from whole blood for the early detection of multiple cancers. The goal of this study is to employ genomics, epigenomics and proteomics methodology for the detection of cancer signal in the blood of subjects with solid tumors.
Detailed description
Epigenomic changes in cancer cells can provide a rich source of biomarker signals for the detection of disease. As cancer cells manifest their epigenomic changes in blood due to cell death, DNA and protein molecules can be probed using specific molecular analytic approaches. ClearNote Health employs epigenomic technologies to measure dynamic changes in DNA demethylation events via direct measurement of 5-hydroxymethyl-cytosine residues in cfDNA. Companion assays are also run to provide information on cfDNA digestion patterns and protein-based changes in plasma. This information, combined in a machine learning framework, enable the provision of prediction models that report on the presence of cancer and the determination of the tissue of tumor origin. This study will build predictive models and test performance of these models to detect the presence of cancer and tissue of origin in several cancer type by using a matched case-control study design.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-cancer | – | Other: Blood Draw10,000 asymptomatic individuals without prior history of cancer |
| Cancer | – | Other: Blood Draw10,000 individuals with confirmed malignancy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Both study groups enrolled at medical centers across the United States
Key inclusion criteria (4 listed)
- Subjects must be between 21-80 years of age at the time of enrollment
- Patient fully consented
- Cancer diagnosis OR high clinical suspicion for cancer, based on the participating site's and practitioner's standards of care (SOC)
- No previous history of cancer and treatment naïve at time of enrollment
Key exclusion criteria (11 listed)
- Age < 21 OR > 80 years of age
- Any prior cancer diagnosis with or without treatment (with the exception of non-melanoma skin cancers resolved/treated > 1 year prior to enrollment)
- Receipt of any cancer therapy including chemotherapy, radiation, palliative radiation, hormonal or naturopathic therapies
- In situ carcinoma without an invasive component
- Any surgery requiring general anesthesia within 2 months of collection. Anesthesia used in procedures such as colonoscopy and EBUS is acceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawBlood Draw | Other | Cancer, Non-cancer |
Primary outcome
Detection of cancer signal in the cancer cohort
Time frame: Baseline
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals in plasma from non-cancer controls
Detection of tissue of origin signal in the cancer cohort
Time frame: Baseline
Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals from non-cancer controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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.
Samuel Levy, Ph.D. study director
ClearNote Health, Inc.
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 Diagnosis of Cancer of Various Organs, run by ClearNote Health at 1 site in United States.
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 11 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Peters, MA, PMP, CCRC (619-277-2160, mpeters@clearnotehealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cancer signal in the cancer cohort (time frame: Baseline). The study lists 2 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 15 May 2026.