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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869814
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Bluestar Genomics Inc.

Study Description
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Brief Summary:
Bluestar Genomics is developing a screening 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 also include subjects without cancers that will be followed up for up to 3-years from blood draw.

Condition or disease Intervention/treatment
Cancer of Various Organs Diagnostic Test: Non-invasive Liquid Biospy

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 Design
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Study Type : Observational
Actual Enrollment : 1800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : June 13, 2020
Actual Study Completion Date : June 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Non-cancer
900 asymptomatic individuals without prior history of cancer
 Diagnostic Test: Non-invasive Liquid Biospy
Non-invasive Liquid Biospy
Cancer
900 individuals with confirmed malignancy
 Diagnostic Test: Non-invasive Liquid Biospy
Non-invasive Liquid Biospy


Outcome Measures
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Primary Outcome Measures :
  1. Detection of cancer signal in the cancer cohort [ Time Frame: 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

  2. Detection of tissue of origin signal in the cancer cohort [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
Whole blood, plasma

Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both study groups enrolled at medical centers across the United States
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869814


Locations
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United States, California
Bluestar Genomics, Inc.
San Diego, California, United States, 92121
Sponsors and Collaborators
Bluestar Genomics Inc.
Investigators
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Study Director: Sam Levy, Ph.D. Bluestar Genomics Inc.
More Information
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Responsible Party: Bluestar Genomics Inc.
ClinicalTrials.gov Identifier: NCT03869814    
Other Study ID Numbers: MT1410
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No