Colorectal Cancer (Diagnosis)ctDNA TAPNCT07310537
Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
An observational study of Colorectal Cancer (Diagnosis) and Colorectal Liver Metastasis (CRLM), run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Cancer (Diagnosis), Colorectal Liver Metastasis (CRLM), Circulating Tumor DNA (ctDNA)
- What is being tested?
- Blood Collection - TAP® Device and Blood Collection - Venous
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Nov 2025to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 21 years
- A history of histologically confirmed (metastatic) colorectal adenocarcinoma
- Currently diagnosed with (progressive) colorectal liver metastases (CRLM)
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC University Medical Center
Rotterdam, South Holland, 3015 GD
Mirthe Ubink, MD, +31650162308, m.ubink@erasmusmc.nl
About this study
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:
Read more
- 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.
Read the detailed description
Rationale: Aging of the general population results in an increasing number of patients who need to be cared for by a decreasing number of health care professionals. To ensure sustainable and patient-centred health care in the near future, rebalanced hospital-based and home-based care is needed. Following surgery of a primary tumour or metastases thereof, patients are offered blood-based follow-up in the hospital, which is necessary to detect recurrence but represents a major burden on the current health care system. The more recently discovered, highly specific circulating tumour-derived DNA fragments (ctDNA) have high potential as a new biomarker and clinical implementation of ctDNA in CRC patient care is expected in the future. However, feasibility of ctDNA detection in blood collected through automated capillary sampling had not yet been investigated.
Objective: to determine the feasibility of ctDNA analysis of blood obtained using automated capillary sampling.
Study design: This proof-of-concept study aims to determine technical feasibility of ctDNA detection in small volumes of capillary blood in 35 patients. Venous blood from the same patients will be used as reference
Study population: All study subjects need to be 21 years or older and provide informed consent to participate in the study. Patients with growing colorectal liver metastases (CRLM) can be included.
Main study endpoint: The primary outcome measure of the study is the agreement between ctDNA measurements in venous versus capillary blood to determine the feasibility of ctDNA analysis through automated capillary blood sampling.
- Conditions
- Colorectal Cancer (Diagnosis), Colorectal Liver Metastasis (CRLM), Circulating Tumor DNA (ctDNA)
- Being tested
- Blood Collection - TAP® Device, Blood Collection - Venous
- Keywords
- Colorectal Cancer, Colorectal Liver Metastasis (CRLM), Circulating Tumor DNA (ctDNA), Automated Capillary Blood Sampling
- Medical subject headings
- Colorectal Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Collection - TAP® DeviceOther
K2EDTA BD Microtainer
Blood Collection - VenousOther
10 mL EDTA Collection Tube
| Study group | Role | What they receive |
|---|---|---|
| ctDNA TAP | Study Group Receives: Other: Blood Collection - TAP® Device; Other: Blood Collection - Venous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start17 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirthe Ubink, Erasmus Medical Center
- Investigators
- Cornelis Verhoef, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310537
- Sponsor's protocol ID
- NL88018.078.24
- Acronym
- ctDNA TAP
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Circulating Tumour DNA (ctDNA) Analysis Using Automated Capillary Blood Sampling
- ClinicalTrials.gov ID
- NCT07310537
- Acronym / sponsor ID
- ctDNA TAP / NL88018.078.24
- Conditions
- Colorectal Cancer (Diagnosis), Colorectal Liver Metastasis (CRLM), Circulating Tumor DNA (ctDNA)
- Keywords
- Colorectal Cancer, Colorectal Liver Metastasis (CRLM), Circulating Tumor DNA (ctDNA), Automated Capillary Blood Sampling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Aging of the general population results in an increasing number of patients who need to be cared for by a decreasing number of health care professionals. To ensure sustainable and patient-centred health care in the near future, rebalanced hospital-based and home-based care is needed. Following surgery of a primary tumour or metastases thereof, patients are offered blood-based follow-up in the hospital, which is necessary to detect recurrence but represents a major burden on the current health care system. The more recently discovered, highly specific circulating tumour-derived DNA fragments (ctDNA) have high potential as a new biomarker and clinical implementation of ctDNA in CRC patient care is expected in the future. However, feasibility of ctDNA detection in blood collected through automated capillary sampling had not yet been investigated.
Objective: to determine the feasibility of ctDNA analysis of blood obtained using automated capillary sampling.
Study design: This proof-of-concept study aims to determine technical feasibility of ctDNA detection in small volumes of capillary blood in 35 patients. Venous blood from the same patients will be used as reference
Study population: All study subjects need to be 21 years or older and provide informed consent to participate in the study. Patients with growing colorectal liver metastases (CRLM) can be included.
Main study endpoint: The primary outcome measure of the study is the agreement between ctDNA measurements in venous versus capillary blood to determine the feasibility of ctDNA analysis through automated capillary blood sampling.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ctDNA TAP | – | Other: Blood Collection - TAP® Device, Other: Blood Collection - VenousStudy Group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 21 years
- A history of histologically confirmed (metastatic) colorectal adenocarcinoma
- Currently diagnosed with (progressive) colorectal liver metastases (CRLM)
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Collection - TAP® DeviceK2EDTA BD Microtainer | Other | ctDNA TAP |
| Blood Collection - Venous10 mL EDTA Collection Tube | Other | ctDNA TAP |
Primary outcome
Technical feasibility of ctDNA detection in small volumes of capillary blood
Time frame: Baseline
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.
1 secondary outcome
Correlation between ctDNA levels (VAF) in venous and capillary blood
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Related trials for Colorectal Cancer (Diagnosis)
Recruiting
MRD Monitoring in Colorectal Cancer Using ctDNA
Colorectal Neoplasms, Colorectal Cancer (Diagnosis)
Not yet recruitingPhase 2
Intestinal Low-Dose Radiotherapy Combined With Immune Checkpoint Inhibitors in Solid Tumors With Liver Metastases
Liver Metastases, Non-Small Cell Lung Cancer
Not yet recruiting
Mind-Body Sexual Well-Being Program for Female GI Cancer Survivors
Colorectal Cancer (Diagnosis), Anal Cancer
RecruitingPhase 2
Ph II Intraperitoneal Paclitaxel + System Therapy in GI Ca w/Peritoneal Carcinomatosis (STOPGAP-B)
Esophageal Carcinoma, Gastric Cancer (Diagnosis)
RecruitingObservational study
Secondary Care Colorectal Cancer Pathway Review
Colorectal Cancer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cornelis Verhoef, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer (Diagnosis) and Colorectal Liver Metastasis (CRLM), run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirthe Ubink, MD (+31650162308, m.ubink@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of ctDNA detection in small volumes of capillary blood (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.