Clinical trial · Interventional
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling
Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to determine the feasibility of CEA assessments at home using (automated) capillary sampling in patients in the follow-up after treatment for colorectal cancer. The main questions it aims to answer are: * To determine the success rate of capillary sampling at home by the patient * To assess reliability and satisfaction of (automated) capillary CEA measurements Participants will be asked to perform automated capillary sampling and lancet capillary sampling at home twice after regular check-up visits in the hospital, with an interval of 3-6 months in between. During this hospital visit, a CEA measurement in blood sampled by venipuncture will be performed to act as a reference for the CEA measurements in (automated) capillary blood to be sampled at home. Reliability of CEA measurements will be assessed for automated capillary and lancet capillary sampling compared to venipuncture. Satisfaction in terms of patient reported outcomes (pain, burden, ease of use, and preference) will be evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lancet capillary sampling | Diagnostic Test | — | UNRESOLVED |
| TAP-II | Diagnostic Test | — | UNRESOLVED |
| Venipuncture | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Subjects with known elevated serum CEA
- description
- Before the start of sample collection questionnaire A on paper will be filled in by all study subjects. The order of sample collection will be: automated capillary sampling, lancet capillary sampling and venipuncture. Herein automated and lancet capillary sampling will be performed by the study subjects themselves whereas the venipuncture will be performed by the study personnel. After all sampling has been completed, the subject is asked to complete questionnaire B which will evaluate pain, burden, ease of use and preference. For subjects in arm A and C this entails the end of the study
- interventionNames
- Diagnostic Test: TAP-II
- Diagnostic Test: Lancet capillary sampling
- Diagnostic Test: Venipuncture
- type
- OTHER
- label
- Subjects currently undergoing colorectal cancer related follow-up
- description
- The subjects of arm B are requested to perform automated capillary and lancet capillary sampling at home following their next two outpatient visits. During these outpatient visits, a reference value blood CEA measurement will be obtained using venipuncture by the personnel of the clinical laboratory of Erasmus MC. The required materials will be sent to the home address of the patient. Sampling will be performed at home and by the subjects themselves. Subjects will have access to the tutorial videos for automated and lancet capillary sampling.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: Arm A: subjects with known elevated serum CEA * Age ≥ 21 years * Histologically confirmed (metastatic) colorectal adenocarcinoma * Serum CEA ≥ 10 μg/L within the last 2 months determined using venipuncture blood sampling Arm B: subjects currently undergoing colorectal cancer related follow-up * Age ≥ 21 years * Histologically confirmed (metastatic) colorectal adenocarcinoma * Currently undergoing in-hospital follow-up with at least two more scheduled serum CEA assessments 3-6 months apart Arm C: volunteers * Age ≥ 21 years * No known history of colorectal adenocarcinoma * No known history of elevated serum CEA ≥ 5 μg/L Exclusion Criteria: * Illiteracy and/or insufficient proficiency of the Dutch language * Severe or complete loss of sensory and or motor function of one or both arms and or hands * 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
References
Publications (2)
- RESULTVoigt KR, Wullaert L, Verhoef C, Grunhagen DJ, Ramakers C. Reliable capillary sampling of carcinoembryonic antigen at home: the CASA feasibility study. Colorectal Dis. 2023 Jun;25(6):1163-1168. doi: 10.1111/codi.16536. Epub 2023 Mar 21. PMID 36945082
- RESULTVoigt KR, Wullaert L, Gobardhan PD, Doornebosch PG, Verhoef C, Husson O, Ramakers C, Grunhagen DJ. Feasibility, reliability and satisfaction of (automated) capillary carcinoembryonic antigen measurements for future home-based blood sampling: the prospective CASA-I study. Colorectal Dis. 2024 Aug;26(8):1560-1568. doi: 10.1111/codi.17085. Epub 2024 Jul 1. PMID 38949106