Clinical trial · Observational
Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
- 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)
The goal of this observational study is to investigate whether circulating tumor-derived DNA (ctDNA) can be reliably detected and analyzed in blood obtained through automated capillary sampling in adult patients (≥21 years) with colorectal liver metastases (CRLM). The main question it aims to answer is: * Can ctDNA be detected in small volumes of capillary blood collected using an automated sampling device? * Do ctDNA levels measured in capillary blood agree with those measured in venous blood from the same patients? Researchers will compare ctDNA measurements from capillary blood to those from venous blood (reference standard) to see if capillary sampling provides reliable results for ctDNA analysis. Participants will: * Provide a small blood sample through automated capillary collection. * Provide a venous blood sample during the same study visit for comparison.
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 |
|---|---|---|---|
| Circulating Tumor DNA (ctDNA) | — | UNRESOLVED | — |
| Colorectal Cancer (Diagnosis) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Liver Metastasis (CRLM) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Collection - TAP® Device | Other | — | UNRESOLVED |
| Blood Collection - Venous | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ctDNA TAP
- description
- Study Group
- interventionNames
- Other: Blood Collection - TAP® Device
- Other: Blood Collection - Venous
Primary outcomes (1)
- measure
- Technical feasibility of ctDNA detection in small volumes of capillary blood
- timeFrame
- Baseline
- description
- This will be investigated through determining the agreement between ctDNA measurements in venous (standard blood collection) versus capillary blood through automated capillary blood sampling. A Kappa \>0.75 will be considered as sufficient agreement.
Secondary outcomes (1)
- measure
- Correlation between ctDNA levels (VAF) in venous and capillary blood
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 21 years * A history of histologically confirmed (metastatic) colorectal adenocarcinoma * Currently diagnosed with (progressive) colorectal liver metastases (CRLM) * Signed informed consent Exclusion Criteria: * Patients who are treated and having a response on chemotherapy, as this may have an effect on the investigated biomarker load * Illiteracy and/or insufficient proficiency of the Dutch language * Known medical history of superficial or deep skin infection after venipuncture or intravenous line that required antibiotic treatment and or hospital admittance * Known medical history of immunodeficiency or current use of medical immunosuppressants * Known medical history of blood-borne diseases such as, but not limited to, the human immunodeficiency virus, hepatitis and viral hemorrhagic fever
References
Publications (0)
Data not yet available