Clinical trial NCT05646030: Feasibility, Reliability, and Satisfaction of CEA Using Home Based (automated) Capillary Blood Sampling
Official title: Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (automated) CApillary Blood SAmpling; the Prospective CASA-I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Capillary sampling
CEA
Colorectal cancer
Home-based
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective three-armed cohort study.
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of CEA assessments at home using (automated) capillary sampling
timeFrame: Year 1 (6 months after the inclusion of the first patient)
Secondary outcomes:
measure: Reliability of the CEA measurements
timeFrame: Year 1 (6 months after the inclusion of the first patient)
measure: Satisfaction of blood sampling
timeFrame: Year 1 (6 months after the inclusion of the first patient)
measure: Clinical laboratory sample processing time:
timeFrame: Year 1 (6 months after the inclusion of the first patient)
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Dirk J. Grünhagen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.