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

Bluestar Genomics 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. The study will include subjects without cancers that will be followed up every 6-months for up to 3-years from blood draw.

Study Overview

• Status: Recruiting
• Conditions: Diagnosis of Cancer of Various Organs
• Intervention / Treatment: Other: Blood Draw

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. Bluestar Genomics 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 Type: Observational
• Enrollment (Anticipated): 6500

Contacts and Locations

• Study Contact: Name: Melissa Peters, MA, PMP, CCRC; Phone Number: 619-277-2160; Email: mpeters@bluestargenomics.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Recruiting
      • Bluestar Genomics, Inc.
      • Contact: Melissa Peters, MA, PMP, CCRC; Phone Number: 833-258-7827; Email: mpeters@bluestargenomics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Both study groups enrolled at medical centers across the United States

Description

Inclusion Criteria

1. Subjects must be between 45 - 75 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 < 45 OR > 75 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. Dental Novocain within 1 week of collection
7. Receipt of systemic immunomodulation therapy within past 12 months
8. Currently pregnant, or pregnancy within last 12 months
9. Organ transplantation
10. Received dialysis
11. Blood transfusion within 1 month
12. 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-cancer; 3,250 asymptomatic individuals without prior history of cancer	Other: Blood Draw; Blood Draw
Cancer; 3,250 individuals with confirmed malignancy	Other: Blood Draw; Blood Draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year

Collaborators and Investigators

• Sponsor: ClearNote Health
• Investigators: Study Director: Samuel Levy, Ph.D., ClearNote Health

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Anticipated): June 13, 2023
• Study Completion (Anticipated): September 13, 2023

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: MT1410

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No