Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types

NCT03869814 | Recruiting

• 1 other identifier: MT1410
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline

Study Arms (2)

Non-cancer

10,000 asymptomatic individuals without prior history of cancer

Other: Blood Draw

Cancer

10,000 individuals with confirmed malignancy

Other: Blood Draw

Interventions

Blood Draw OTHER

Blood Draw

Cancer; Non-cancer

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both study groups enrolled at medical centers across the United States

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• ClearNote Health: lead

Study Sites (1)

ClearNote Health, Inc.

San Diego, California, 92121, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, plasma

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Samuel Levy, Ph.D.

  ClearNote Health, Inc.

  STUDY DIRECTOR

Central Study Contacts

Melissa Peters, MA, PMP, CCRC

CONTACT

619-277-2160; mpeters@clearnotehealth.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 11, 2019
• Study Start: April 5, 2018
• Primary Completion (Estimated): June 13, 2029
• Study Completion (Estimated): September 13, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)