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

Summary

ClearNote Health 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.

Eligibility

Inclusion Criteria

1. Subjects must be between 21-80 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 \< 21 OR \> 80 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. Receipt of systemic immunomodulation therapy within past 12 months
7. Currently pregnant, or pregnancy within last 12 months
8. Organ transplantation
9. Received dialysis
10. Blood transfusion within 1 month
11. Known 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.

Conditions2

Locations1 site

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