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

NCT07310537 | Recruiting

• 1 other identifier: NL88018.078.24
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Circulating Tumor DNA (ctDNA); Colorectal Liver Metastasis (CRLM); Colorectal Cancer (Diagnosis)

Keywords

Colorectal Cancer; Colorectal Liver Metastasis (CRLM); Circulating Tumor DNA (ctDNA); Automated Capillary Blood Sampling

Outcome Measures

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.

  Baseline

Secondary Outcomes (1)

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

  Baseline

Study Arms (1)

ctDNA TAP

Study Group

Other: Blood Collection - TAP® Device; Other: Blood Collection - Venous

Interventions

Blood Collection - TAP® Device OTHER

K2EDTA BD Microtainer

ctDNA TAP

Blood Collection - Venous OTHER

10 mL EDTA Collection Tube

ctDNA TAP

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10 mL venous blood samples will be collected in EDTA tubes, and capillary blood samples will be collected using a K2EDTA Microtainer®.

MeSH Terms

Conditions

Colorectal Neoplasms; Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cornelis Verhoef, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mirthe Ubink, MD

CONTACT

+31650162308; m.ubink@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

NL (1)