Colorectal CancerCASA-INCT05646030
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling
A study testing TAP-II, Lancet capillary sampling and Venipuncture in people with Colorectal Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- TAP-II, Lancet capillary sampling and Venipuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Mar 2022to 26 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study
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:
Read more
- 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- TAP-II, Lancet capillary sampling, Venipuncture
- Keywords
- Capillary sampling, CEA, Colorectal cancer, Home-based
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP-IIDiagnostic test
The TAP-II device will be compared to lancet capillary sampling and the venipuncture
Lancet capillary samplingDiagnostic test
The lancet capillary sampling will be compared to TAP device and the venipuncture
VenipunctureDiagnostic test
The venipuncture will be compared to TAP device and the lancet capillary sampling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Diagnostic Test: TAP-II; Diagnostic Test: Lancet capillary sampling; Diagnostic Test: Venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 1 (6 months after the inclusion of the first patient)
Secondary outcomes (3)
Reliability of the CEA measurements
Reliability will be assessed by a Bland-Altman analysis to determine mean bias and the 95% limits of agreement of measurements from (automated) capillary samples compared to venipuncture samples. These will be compared to predefined clinically relevant cut-off values for the mean bias and the limits of agreement. A mean bias of greater or equal to +/- 5% and or 95% limits of agreement equal to or greater than +/- 10% will be considered clinically relevant and thereby unreliable. These cut-off values are defined based on previously found 95% limits of agreement of the automated capillary sampling device and the precision of the Cobas 8000 analyzer which will be used to perform the CEA analyses.
Measured: Year 1 (6 months after the inclusion of the first patient)
Satisfaction of blood sampling
All study subjects will be asked to complete the questionnaire to evaluate pain, burden, ease of use and preference. Herein they are asked to provide their perceived level of pain separately for automated capillary sampling, lancet capillary sampling and venipuncture. A visual analogue scale ranging from 0 to 10 will be used to measure perceived level of pain. Pain measurements will be compared across all three sampling methods in the entire cohort of 100 subjects using repeated measures ANOVA. An α < 0.05 will be considered statistically significant.
Measured: Year 1 (6 months after the inclusion of the first patient)
Clinical laboratory sample processing time:
the sample processing time from entering the clinical laboratory until a successful measurement is obtained will be compared across all sampling methods using analysis of variance (ANOVA). An α < 0.05 will be considered statistically significant.
Measured: Year 1 (6 months after the inclusion of the first patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start25 Mar 2022
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective three-armed cohort study.
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D.J. (Dirk) Grünhagen, Erasmus Medical Center
- Investigators
- Dirk J. Grünhagen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646030
- Sponsor's protocol ID
- NL78309.078.21
- Acronym
- CASA-I
- Status last verified
- Sep 2024
- First submitted
- 2 Dec 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36945082Voigt 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.
PubMed 38949106
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study
- ClinicalTrials.gov ID
- NCT05646030
- Acronym / sponsor ID
- CASA-I / NL78309.078.21
- Conditions
- Colorectal Cancer
- Keywords
- Capillary sampling, CEA, Colorectal cancer, Home-based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A prospective three-armed cohort study.
| Arm | Type | Receives |
|---|---|---|
| Subjects with known elevated serum CEA | Other | Diagnostic Test: TAP-II, Diagnostic Test: Lancet capillary sampling, Diagnostic Test: VenipunctureBefore 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 |
| Subjects currently undergoing colorectal cancer related follow-up | Other | Diagnostic Test: TAP-II, Diagnostic Test: Lancet capillary sampling, Diagnostic Test: VenipunctureThe 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. |
| Volunteers | Other | Diagnostic Test: TAP-II, Diagnostic Test: Lancet capillary sampling, Diagnostic Test: VenipunctureBefore 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP-IIThe TAP-II device will be compared to lancet capillary sampling and the venipuncture | Diagnostic test | Subjects currently undergoing colorectal cancer related follow-up, Subjects with known elevated serum CEA, Volunteers |
| Lancet capillary samplingThe lancet capillary sampling will be compared to TAP device and the venipuncture | Diagnostic test | Subjects currently undergoing colorectal cancer related follow-up, Subjects with known elevated serum CEA, Volunteers |
| VenipunctureThe venipuncture will be compared to TAP device and the lancet capillary sampling | Diagnostic test | Subjects currently undergoing colorectal cancer related follow-up, Subjects with known elevated serum CEA, Volunteers |
Primary outcome
Feasibility of CEA assessments at home using (automated) capillary sampling
Time frame: 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.
3 secondary outcomes
Reliability of the CEA measurements
Time frame: Year 1 (6 months after the inclusion of the first patient)
Satisfaction of blood sampling
Time frame: Year 1 (6 months after the inclusion of the first patient)
Clinical laboratory sample processing time:
Time frame: Year 1 (6 months after the inclusion of the first patient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Results publication: PubMed 36945082Voigt 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.
- Results publication: PubMed 38949106Voigt 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.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk J. Grünhagen, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP-II, Lancet capillary sampling and Venipuncture in people with Colorectal Cancer, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of CEA assessments at home using (automated) capillary sampling (time frame: Year 1 (6 months after the inclusion of the first patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646030, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.