colon cancer Colorectal cancer
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Group A: Age >= 21 years Histologically confirmed (metastatic) colorectal adenocarcinoma Serum CEA >= 10 µg/L within the last 2 months determined using venipuncture blood sampling Group B: 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 Group C: Age >= 21 years No known history of colorectal adenocarcinoma No known history of elevated serum CEA >= 5 µg/L
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to determine feasibility of CEA assessments at home using (automated) capillary sampling. Home based (automated) capillary sampling will be considered feasible if a success rate of 85% or greater has been reached. Herein a successful (automated) capillary sampling at home is defined as a sampling of blood by the patient that reached the clinical laboratory of the hospital and in which a CEA level could be determined reliably and that was comparable to the prior measurement sampled by venipuncture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the study are to assess reliability and satisfaction of (automated) capillary CEA measurements. Blood samples collected under identical pre-analytical conditions using automated capillary sampling, lancet capillary sampling and venipuncture will be compared on agreement using Bland-Altman analysis 39. Herein the measurement obtained from the venipuncture sample will be considered the golden standard. The mean bias and corresponding 95% limits of agreement of (automated) capillary samples and the golden standard will be calculated. A mean bias of +/- 5% or greater and 95% limits of agreement of greater than +/- 10% will be considered clinically relevant and thereby unreliable. Satisfaction of (automated) capillary sampling will be evaluated in terms of patient reported outcome measures on pain, burden, ease of use, and preference. Perceived levels of pain measured on a visual analogue scale (VAS) will be compared across automated capillary sampling, lancet capillary sampling, and venipuncture. It is hypothesized that automated capillary sampling will be perceived as least painful, least burdensome, most easy to use, and will be the preferred method of blood sampling for the majority of study subjects. Finally, the clinical laboratory sample processing time will be compared across automated capillary sampling, lancet capillary sampling, and venipuncture. | — |
Countries
Netherlands
Outcome results
None listed