Detecting tumor DNA in small automated capillary blood samples from adults with colorectal cancer liver metastases.
Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
This project will try whether tiny automated capillary (finger‑prick) blood samples can detect circulating tumor DNA in adults with colorectal cancer that has spread to the liver.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT07310537 on ClinicalTrials.gov |
What this trial studies
This observational proof-of-concept will enroll 35 adults with progressive colorectal liver metastases to test whether ctDNA can be identified in small automated capillary blood samples. Each participant will provide a capillary sample collected with a TAP® device and a simultaneous venous blood draw as the reference standard. Researchers will compare ctDNA presence and quantitative agreement between capillary and venous samples to determine technical feasibility. Patients on active responsive chemotherapy, those with certain blood‑borne infections or immunodeficiency, or with recent venipuncture‑related skin infections are excluded per protocol.
Who should consider this trial
Good fit: Ideal candidates are adults (≥21) with histologically confirmed colorectal adenocarcinoma and progressive colorectal liver metastases who can give informed consent and communicate in Dutch.
Not a fit: Patients who are currently responding to chemotherapy, have immunodeficiency or certain blood‑borne infections, recent venipuncture‑related skin infections, or who cannot consent or speak Dutch are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, capillary ctDNA sampling could enable easier, less invasive monitoring and support more home‑based follow-up for colorectal cancer patients.
How similar studies have performed: While ctDNA analysis from venous blood is well established, use of automated capillary sampling for ctDNA is novel and has not been validated in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rotterdam, South Holland
- Erasmus MC University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Cornelis Verhoef, MD, PhD — Erasmus Medical Center
- Study coordinator: Mirthe Ubink, MD
- Email: m.ubink@erasmusmc.nl
- Phone: +31650162308
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.