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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with known elevated serum CEA | Other | 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 |
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| Subjects currently undergoing colorectal cancer related follow-up | Other | 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. |
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| Volunteers | Other | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP-II | Diagnostic Test | The TAP-II device will be compared to lancet capillary sampling and the venipuncture |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Year 1 (6 months after the inclusion of the first patient) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Arm A: subjects with known elevated serum CEA
Arm B: subjects currently undergoing colorectal cancer related follow-up
Arm C: volunteers
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk J. Grünhagen, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | South Holland | 3015 GD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36945082 | Result | Voigt 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. | |
| 38949106 | Result | Voigt 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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A prospective three-armed cohort study.
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|
| Lancet capillary sampling | Diagnostic Test | The lancet capillary sampling will be compared to TAP device and the venipuncture |
|
| Venipuncture | Diagnostic Test | The venipuncture will be compared to TAP device and the lancet capillary sampling |
|
| 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. | 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. | Year 1 (6 months after the inclusion of the first patient) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |