About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 21 years
A history of histologically confirmed (metastatic) colorectal adenocarcinoma
Currently diagnosed with (progressive) colorectal liver metastases (CRLM)
Signed informed consent
Disqualifiers
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
Trial population
All study subjects need to be 21 years or older and provide informed consent to participate in the study. Patients with newly diagnosed/and or progressive colorectal liver metastases (CRLM) can be included.
Trial design
Other
Prospective
Treatments tested in this trial
Blood Collection - TAP® Device
Other interventionK2EDTA BD Microtainer
Blood Collection - Venous
Other intervention10 mL EDTA Collection Tube
Treatment groups
Trial outcomes
Primary outcomes
Technical feasibility of ctDNA detection in small volumes of capillary blood
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
Correlation between ctDNA levels (VAF) in venous and capillary blood
A correlation coefficient of \>0.5 will be considered as sufficient.
Sponsors and contacts
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