Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
Recruiting · NCT07310537 · Observational (researchers observe without assigning treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Erasmus MC University Medical Center - Rotterdam, South Holland, Netherlands