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

This trial does not accept healthy volunteers

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 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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Blood Collection - TAP® Device

    Other intervention

    K2EDTA BD Microtainer

  • Blood Collection - Venous

    Other intervention

    10 mL EDTA Collection Tube

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: ctDNA TAP2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline

Secondary outcomes

1

Correlation between ctDNA levels (VAF) in venous and capillary blood

A correlation coefficient of \>0.5 will be considered as sufficient.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.