Diagnosis of Cancer of Various Organs
Conditions
Brief 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.
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. ClearNote Health 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.
Interventions
OTHERBlood Draw
Blood Draw
Sponsors
ClearNote Health
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of cancer signal in the cancer cohort | Baseline | 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 |
| Detection of tissue of origin signal in the cancer cohort | Baseline | Evaluation of genomics, proteomic and epigenomics signals, such as 5-hydroxymethylcytosine (5hmC), contained in plasma, in comparison to these signals from non-cancer controls |
Countries
United States
Contacts
CONTACTMelissa Peters, MA, PMP, CCRC
STUDY_DIRECTORSamuel Levy, Ph.D.
ClearNote Health, Inc.
Outcome results
None listed