Status:
UNKNOWN
Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
Lead Sponsor:
ClearNote Health
Conditions:
Diagnosis of Cancer of Various Organs
Eligibility:
All Genders
45-75 years
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 detect...
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 pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 13 2023
Estimated Enrollment :
6500 Patients enrolled
Trial Details
Trial ID
NCT03869814
Start Date
April 5 2018
End Date
September 13 2023
Last Update
May 5 2022
Active Locations (1)
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1
Bluestar Genomics, Inc.
San Diego, California, United States, 92121