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NCT05646030
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling
Conditions: Colorectal Cancer
Sex: All
Ages: 21 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Erasmus Medical Center
Location: Netherlands
Summary
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 patientTo 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.
Eligibility Criteria
Inclusion Criteria:Arm A: subjects with known elevated serum CEAAge ≥ 21 yearsHistologically confirmed (metastatic) colorectal adenocarcinomaSerum CEA ≥ 10 μg/L within the last 2 months determined using venipuncture blood samplingArm B: subjects currently undergoing colorectal cancer related follow-upAge ≥ 21 yearsHistologically confirmed (metastatic) colorectal adenocarcinomaCurrently undergoing in-hospital follow-up with at least two more scheduled serum CEA assessments 3-6 months apartArm C: volunteersAge ≥ 21 yearsNo known history of colorectal adenocarcinomaNo known history of elevated serum CEA ≥ 5 μg/LExclusion Criteria:Illiteracy and/or insufficient proficiency of the Dutch languageSevere or complete loss of sensory and or motor function of one or both arms and or handsKnown medical history of superficial or deep skin infection after venipuncture or intravenous line that required antibiotic treatment and or hospital admittanceKnown medical history of immunodeficiency or current use of medical immunosuppressantsKnown medical history of blood-borne diseases such as but not limited to the human immunodeficiency virus, hepatitis and viral hemorrhagic fever
Source: ClinicalTrials.gov (NCT05646030). StuddyBuddy aggregates publicly available trial information.