Clinical trial · Observational
Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA
Characterization of Methylation Patterns in Cancer and Non-Cancer cfDNA, An Observational Multicenter Study
- 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)
Nucleix EpiCheck® tests analyzes the methylation pattern in a panel of DNA methylation biomarkers and determines whether this pattern is consistent with cancer under test or with non-cancer tissue. This study is being performed as part of the development process of the Pan Cancer EpiCheck test which includes the identification of different methylation profiles in various cancer types and healthy controls.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases Group
- description
- Peripheral blood collection via routine venipuncture
- interventionNames
- Procedure: Blood collection
- label
- Control Group
- description
- Peripheral blood collection via routine venipuncture
- interventionNames
- Procedure: Blood collection
Primary outcomes (2)
- measure
- To collect blood and urine samples and clinical data in order to characterize methylation patterns that will discriminate cancer and normal (non-cancer) samples and the origin of cancer
- timeFrame
- 72 Months
- description
- To collect blood and urine samples and clinical data in order to characterize methylation patterns that will discriminate cancer and normal (non-cancer) samples and the origin of cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria - Cases: 1. Age ≥ 22 years 2. Subjects who are willing and able to provide written informed consent. 3. Subjects with confirmed diagnosis of cancer (primary or recurrent) at all stages, however did not yet undergo any surgery, chemotherapy, radiation or any other treatment for this cancerous lesion (including, but not limited to systemic therapies). Recent cancer staging should be within 60 days prior to baseline visit. Exclusion Criteria - Cases: 1. Known prior diagnosis of cancer except of: 1. Fully resected non-melanoma skin cancer 2. History of the original cancer in cases of recurrent disease. 2. Current co-diagnosis of another type of cancer. 3. Currently receiving, or ever received, any of the following therapies to treat their current cancer: surgical management of the cancer beyond that required to establish the cancer diagnosis; local, regional or systemic chemotherapy including chemoembolization; targeted therapy, immunotherapy including cancer vaccines; hormone therapy; or radiation therapy 4. Pregnancy (by self-report) 5. Current febrile illness 6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw. 7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant Inclusion Criteria - Controls: 1. Age 45 to 80 years 2. Subjects who are willing and able to provide written informed consent Exclusion Criteria - Controls: 1. Known current or prior diagnosis of cancer except of fully resected non-melanoma skin cancer 2. Currently in work-up due to suspicion of cancer of any kind 3. Oral or IV corticosteroid use in past 14 days prior to blood draw 4. Pregnancy (by self-report) 5. Current febrile illness 6. Acute exacerbation or flare of an inflammatory condition requiring escalation in medical therapy within 14 days prior to blood draw. 7. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant 8. Life expectancy \< 24 months
References
Publications (0)
Data not yet available