NCT05646030Completed
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling
Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 2 Dec 2022
- Start date
- 25 Mar 2022
- Primary completion date
- 26 Aug 2024
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT05646030
What you commit to
- Study type: Interventional
- Participants enrolled: 102
- From 25 Mar 2022 to the primary completion date, 26 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.