Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Feasibility of CEA assessments at home using (automated) capillary sampling
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility of CEA assessments at home using (automated) capillary sampling
时间窗: Year 1 (6 months after the inclusion of the first patient)
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.
次要结局
- Reliability of the CEA measurements(Year 1 (6 months after the inclusion of the first patient))
- Clinical laboratory sample processing time:(Year 1 (6 months after the inclusion of the first patient))
- Satisfaction of blood sampling(Year 1 (6 months after the inclusion of the first patient))
研究者
D.J. (Dirk) Grünhagen
Principal Investigator
Erasmus Medical Center