Clinical trial · Observational
Non-invasive Liquid Biopsy Analysis of Epigenomics Signatures in Multiple Cancer Types
NCT03869814CI-TRIAL-00111768recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnosis of Cancer of Various Organs | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Draw | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Non-cancer
- description
- 10,000 asymptomatic individuals without prior history of cancer
- interventionNames
- Other: Blood Draw
- label
- Cancer
- description
- 10,000 individuals with confirmed malignancy
- interventionNames
- Other: Blood Draw
Primary outcomes (2)
- measure
- Detection of cancer signal in the cancer cohort
- timeFrame
- Baseline
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.