Recruiting

Liquid Biopsy

Sponsor:

ClearNote Health

Code:

NCT03869814

Conditions

Diagnosis of Cancer of Various Organs

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Blood Draw

Study Details

Brief 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.

Conditions

Diagnosis of Cancer of Various Organs

Study ID

NCT03869814

Start date

Apr 5, 2018

Status verified date

Apr, 2026

Completion date

Sep 13, 2029

Anticipated

Primary completion date

Jun 13, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

20000 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-cancer

10,000 asymptomatic individuals without prior history of cancer

Cancer

10,000 individuals with confirmed malignancy

Interventions

Blood Draw

Blood Draw

Primary outcome measure

  • Detection of cancer signal in the cancer cohort [ Time Frame: Baseline ]
  • Detection of tissue of origin signal in the cancer cohort [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Melissa Peters, MA, PMP, CCRC

619-277-2160mpeters@clearnotehealth.com

Locations

ClearNote Health, Inc.

Recruiting

San Diego, California, United States, 92121

Contacts

Melissa Peters, MA, PMP, CCRC

833-258-7827mpeters@clearnotehealth.com

More Information

Sponsor

ClearNote Health

Last update posted

May 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by ClearNote Health on 2026-05-15.