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

NCT05646030 | Completed

• 1 other identifier: NL78309.078.21
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Capillary sampling; CEA; Colorectal cancer; Home-based

Outcome Measures

Primary Outcomes (1)

• Feasibility of CEA assessments at home using (automated) capillary sampling

  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.

  Year 1 (6 months after the inclusion of the first patient)

Secondary Outcomes (3)

• Reliability of the CEA measurements

  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)

• Clinical laboratory sample processing time:

  Year 1 (6 months after the inclusion of the first patient)

Study Arms (3)

Subjects with known elevated serum CEA

OTHER

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

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

Subjects currently undergoing colorectal cancer related follow-up

OTHER

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.

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

Volunteers

OTHER

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

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

Interventions

TAP-II DIAGNOSTIC_TEST

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

Subjects currently undergoing colorectal cancer related follow-up; Subjects with known elevated serum CEA; Volunteers

Lancet capillary sampling DIAGNOSTIC_TEST

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

Subjects currently undergoing colorectal cancer related follow-up; Subjects with known elevated serum CEA; Volunteers

Venipuncture DIAGNOSTIC_TEST

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

Subjects currently undergoing colorectal cancer related follow-up; Subjects with known elevated serum CEA; Volunteers

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 36945082 BACKGROUND

• 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.

  PMID: 38949106 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dirk J. Grünhagen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective three-armed cohort study.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 12, 2022
• Study Start: March 25, 2022
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)