Non-invasive blood test to detect cancer and identify tissue origin
Official title: Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
Run by ClearNote Health · NCT03869814 · Data updated 2026-11-12
A blood-based test is being developed to see if cancer signals can be found in people with solid tumors, using genomics and protein data from cfDNA and plasma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 80 Years |
| Sex | All |
| Enrollment | 20000 (estimated) |
| Sponsor | ClearNote Health Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | April 5, 2018 |
| Main results expected | June 13, 2029 |
| Study ends | September 13, 2029 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT03869814 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21 to 80 with a cancer diagnosis or strong clinical suspicion of cancer, who have not received cancer therapy and have no invasive cancer history.
✕Probably not a fit
Patients with cancers outside the studied types or those unable to provide adequate blood samples may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study uses whole-blood samples to develop predictive models that detect cancer and determine its tissue of origin. It integrates epigenomic, genomic, and proteomic data from circulating cell-free DNA and plasma proteins. A matched case-control design is used to build and test models that predict cancer presence and origin across several cancer types. The study relies on machine-learning approaches to combine multiple biomarker signals with clinical information. Participants include adults suspected of or diagnosed with cancer, with blood draws as the primary procedure.
Why it matters
Potential benefit: If successful, the test could enable earlier cancer detection and help identify where a cancer originated.
How similar studies have gone: Prior studies show that multi-omics blood-based approaches can detect cancer signals, though tissue-origin prediction remains challenging and is being actively explored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Subjects must be between 21-80 years of age at the time of enrollment 2. Patient fully consented 3. Cancer diagnosis OR high clinical suspicion for cancer, based on the participating site's and practitioner's standards of care (SOC) 4. No previous history of cancer and treatment naïve at time of enrollment Exclusion Criteria 1. Age \< 21 OR \> 80 years of age 2. Any prior cancer diagnosis with or without treatment (with the exception of non-melanoma skin cancers resolved/treated \> 1 year prior to enrollment) 3. Receipt of any cancer therapy including chemotherapy, radiation, palliative radiation, hormonal or naturopathic therapies 4. In situ carcinoma without an invasive component 5. Any surgery requiring general anesthesia within 2 months of collection. Anesthesia used in procedures such as colonoscopy and EBUS is acceptable. 6. Receipt of systemic immunomodulation therapy within past 12 months 7. Currently pregnant, or pregnancy within last 12 months 8. Organ transplantation 9. Received dialysis 10. Blood transfusion within 1 month 11. 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.
Where it's running
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ClearNote Health, Inc.
San Diego, California, United States Recruiting
Study contacts
- Study coordinator: Melissa Peters, MA, PMP, CCRC
- Email: mpeters@clearnotehealth.com
- Phone: 619-277-2160
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.