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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-05

Study Completion Date

2023-09-13

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.

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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.

Conditions

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Diagnosis of Cancer of Various Organs

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-cancer

3,250 asymptomatic individuals without prior history of cancer

Blood Draw

Intervention Type OTHER

Blood Draw

Cancer

3,250 individuals with confirmed malignancy

Blood Draw

Intervention Type OTHER

Blood Draw

Interventions

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Blood Draw

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes