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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diagnosis of Cancer of Various Organs

Intervention / Treatment
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* Other: Blood Draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subjects must be between 45 - 75 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 Exclusion Criteria Age < 45 OR > 75 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. Dental Novocain within 1 week of collection 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 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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-cancer<br>3,250 asymptomatic individuals without prior history of cancer | Other: Blood Draw<br>* Blood Draw<br>|
| Cancer<br>3,250 individuals with confirmed malignancy | Other: Blood Draw<br>* Blood Draw<br>|

What is the study measuring?
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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 |