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

NCT05646030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-09-25

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

TAP-II

The TAP-II device will be compared to lancet capillary sampling and the venipuncture

DIAGNOSTIC_TEST

Lancet capillary sampling

The lancet capillary sampling will be compared to TAP device and the venipuncture

DIAGNOSTIC_TEST

Venipuncture

The venipuncture will be compared to TAP device and the lancet capillary sampling

Sponsors & Collaborators

Principal Investigators

  • Dirk J. Grünhagen, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-25
Primary Completion
2024-08-26
Completion
2024-08-26

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646030 on ClinicalTrials.gov