Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
- Conditions
- Diagnosis of Cancer of Various Organs
- Interventions
- Other: Blood Draw
- Registration Number
- NCT03869814
- Lead Sponsor
- ClearNote Health
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-cancer Blood Draw 3,250 asymptomatic individuals without prior history of cancer Cancer Blood Draw 3,250 individuals with confirmed malignancy
- Primary Outcome Measures
Name Time Method Detection of tissue of origin signal in the cancer cohort 1 year Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals from non-cancer controls
Detection of cancer signal in the cancer cohort 1 year 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bluestar Genomics, Inc.
🇺🇸San Diego, California, United States