UnknownNot Applicable

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

United States6,500 participantsStarted 2018-04-05

Plain-language 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.

Who can participate

Age range45 Years – 75 Years

SexALL

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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

What they're measuring

Detection of cancer signal in the cancer cohort

Timeframe: 1 year

Detection of tissue of origin signal in the cancer cohort

Timeframe: 1 year

Trial details

NCT IDNCT03869814

SponsorClearNote Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-06-13

Contact for this trial

Melissa Peters, MA, PMP, CCRC

619-277-2160 mpeters@bluestargenomics.com

View on ClinicalTrials.gov More Diagnosis of Cancer of Various Organs trials