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

  • STATUS
    Recruiting
  • End date
    Sep 13, 2023
  • participants needed
    6500
  • sponsor
    Bluestar Genomics Inc.
Updated on 16 May 2022
Accepts healthy volunteers

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.

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.

Details
Condition Diagnosis of Cancer of Various Organs
Treatment Blood draw
Clinical Study IdentifierNCT03869814
SponsorBluestar Genomics Inc.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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