RecruitingNCT07310537

Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling


Sponsor

Erasmus Medical Center

Enrollment

35 participants

Start Date

Nov 17, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 21 Years

Inclusion Criteria4

  • Age ≥ 21 years
  • A history of histologically confirmed (metastatic) colorectal adenocarcinoma
  • Currently diagnosed with (progressive) colorectal liver metastases (CRLM)
  • Signed informed consent

Exclusion Criteria5

  • 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

Interventions

OTHERBlood Collection - TAP® Device

K2EDTA BD Microtainer

OTHERBlood Collection - Venous

10 mL EDTA Collection Tube


Locations(1)

Erasmus MC University Medical Center

Rotterdam, South Holland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07310537


Related Trials