An interventional study of TAP-II and Lancet capillary sampling in Colorectal Cancer, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Erasmus Medical Center · Not applicable, Interventional, and Screening
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:
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.
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 102 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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Arm A: subjects with known elevated serum CEA
Arm B: subjects currently undergoing colorectal cancer related follow-up
Arm C: volunteers
Exclusion Criteria:
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
Diagnostic Test: TAP-II · Diagnostic Test: Lancet capillary sampling · Diagnostic Test: Venipuncture
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.
Diagnostic Test: TAP-II · Diagnostic Test: Lancet capillary sampling · Diagnostic Test: Venipuncture
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
Diagnostic Test: TAP-II · Diagnostic Test: Lancet capillary sampling · Diagnostic Test: Venipuncture
The TAP-II device will be compared to lancet capillary sampling and the venipuncture
The lancet capillary sampling will be compared to TAP device and the venipuncture
The venipuncture will be compared to TAP device and the lancet capillary sampling
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 via post and in which a CEA level could be determined reliably. Both capillary sampling methods will be analysed and compared to venepuncture separately.
Time frame: Year 1 (6 months after the inclusion of the first patient)
Reliability of the CEA measurements
Reliability will be assessed by a Bland-Altman analysis to determine mean bias and the 95% limits of agreement of measurements from (automated) capillary samples compared to venipuncture samples. These will be compared to predefined clinically relevant cut-off values for the mean bias and the limits of agreement. A mean bias of greater or equal to +/- 5% and or 95% limits of agreement equal to or greater than +/- 10% will be considered clinically relevant and thereby unreliable. These cut-off values are defined based on previously found 95% limits of agreement of the automated capillary sampling device and the precision of the Cobas 8000 analyzer which will be used to perform the CEA analyses.
Time frame: Year 1 (6 months after the inclusion of the first patient)
Satisfaction of blood sampling
All study subjects will be asked to complete the questionnaire to evaluate pain, burden, ease of use and preference. Herein they are asked to provide their perceived level of pain separately for automated capillary sampling, lancet capillary sampling and venipuncture. A visual analogue scale ranging from 0 to 10 will be used to measure perceived level of pain. Pain measurements will be compared across all three sampling methods in the entire cohort of 100 subjects using repeated measures ANOVA. An α \< 0.05 will be considered statistically significant.
Time frame: Year 1 (6 months after the inclusion of the first patient)
Clinical laboratory sample processing time:
the sample processing time from entering the clinical laboratory until a successful measurement is obtained will be compared across all sampling methods using analysis of variance (ANOVA). An α \< 0.05 will be considered statistically significant.
Time frame: Year 1 (6 months after the inclusion of the first patient)
Plan to share: No
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