Feasibility, Reliability, and Satisfaction of CEA Using Home Based (automated) Capillary Blood Sampling

Launched by ERASMUS MEDICAL CENTER · Dec 2, 2022

Keywords

ClinConnect Summary

The follow-up of patients after colorectal cancer surgery mainly consists of blood CEA assessments. These blood assessments could be done at home and could be beneficial in terms of patients' well-being and societal cost-effectiveness. Capillary blood sampling can be an alternative to venipuncture in home based or decentralized surveillance as it can be performed by the patient themselves. Before home based capillary sampling can be implemented, feasibility, reliability, and satisfaction for serum CEA measurements has to be determined.

Gender

ALL

Eligibility criteria

• 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

Trial Officials