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

Colorectal Cancer Clinical Trial

— CASA-I  

Official title:

Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646030
• Other study ID #: NL78309.078.21
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Erasmus Medical Center
• Contact: Kelly R Voigt, MD
• Phone: +31107042125
• Email: k.voigt[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 patient

• To 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• TAP-II
The TAP-II device will be compared to lancet capillary sampling and the venipuncture
• Lancet capillary sampling
The lancet capillary sampling will be compared to TAP device and the venipuncture
• Venipuncture
The venipuncture will be compared to TAP device and the lancet capillary sampling

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	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.	Year 1 (6 months after the inclusion of the first patient)
Secondary	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 a < 0.05 will be considered statistically significant.	Year 1 (6 months after the inclusion of the first patient)
Secondary	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 a < 0.05 will be considered statistically significant.	Year 1 (6 months after the inclusion of the first patient)