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

Erasmus University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Diagnostic Test: TAP-II; Diagnostic Test: Lancet capillary sampling; Diagnostic Test: Venipuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05646030

NL78309.078.21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Subjects with known elevated serum CEA

Other group

Description:

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

Treatment:

Diagnostic Test: Venipuncture

Diagnostic Test: Lancet capillary sampling

Diagnostic Test: TAP-II

Subjects currently undergoing colorectal cancer related follow-up

Other group

Description:

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.

Treatment:

Diagnostic Test: Venipuncture

Diagnostic Test: Lancet capillary sampling

Diagnostic Test: TAP-II

Volunteers

Other group

Description:

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

Treatment:

Diagnostic Test: Venipuncture

Diagnostic Test: Lancet capillary sampling

Diagnostic Test: TAP-II