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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorErasmus Medical Center

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

Qualifiers

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 design

Treatments tested in this trial

  • Blood Collection - TAP® Device
  • Blood Collection - Venous

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators