The primary objective of the study is to determine 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…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is to determine 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 and in which a CEA level could be
determined reliably and that was comparable to the prior measurement sampled by
venipuncture.
Secondary outcome
Secondary objectives of the study are to assess reliability and satisfaction of
(automated) capillary CEA measurements. Blood samples collected under identical
pre-analytical conditions using automated capillary sampling, lancet capillary
sampling and venipuncture will be compared on agreement using Bland-Altman
analysis 39. Herein the measurement obtained from the venipuncture sample will
be considered the golden standard. The mean bias and corresponding 95% limits
of agreement of (automated) capillary samples and the golden standard will be
calculated. A mean bias of +/- 5% or greater and 95% limits of agreement of
greater than +/- 10% will be considered clinically relevant and thereby
unreliable.
Satisfaction of (automated) capillary sampling will be evaluated in terms of
patient reported outcome measures on pain, burden, ease of use, and preference.
Perceived levels of pain measured on a visual analogue scale (VAS) will be
compared across automated capillary sampling, lancet capillary sampling, and
venipuncture. It is hypothesized that automated capillary sampling will be
perceived as least painful, least burdensome, most easy to use, and will be the
preferred method of blood sampling for the majority of study subjects.
Finally, the clinical laboratory sample processing time will be compared across
automated capillary sampling, lancet capillary sampling, and venipuncture.
Background summary
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
Traditional blood sampling by venipuncture is rather unsuitable for home based
sampling due to associated pain and its dependency on medical personnel.
Furthermore, excessive fear of needles is an often neglected aspect of
venipuncture, as it affects at least 10% of the population. To truly enable
home based CEA assessments, evaluation of novel blood sampling techniques that
are associated with less pain, that do not require the use of needles and that
can be performed independent of medical personnel are necessitated.
Capillary blood sampling can be an alternative to venipuncture in home based or
decentralized surveillance as it can be performed by the patient themselves.
Traditional capillary sampling is done by using a lancet to puncture the skin
of a finger. The resulting skin defect allows for blood sampling by repeatedly
applying pressure to the finger. This generates droplets of blood at the
barrier defect which can be collected one by one in a small capillary blood
tube. Although lancet capillary sampling will likely allow successful sampling
at home, some drawbacks still remain. The procedure involves multiple steps
that require some degree of fine motor skill and involves inflicting a small
amount of pain on oneself.
Recently new capillary sampling devices have been developed that automate the
sampling, collection and storage of capillary blood into a single painless
action. Such novel devices would be ideal for blood sampling in decentralized
surveillance strategies. Home based sampling could also be implemented in
centralized surveillance. It could reduce the number of hospital visitations,
as blood sampling and consultations are often separate visits. Before home
based capillary sampling can be implemented, feasibility, reliability, and
satisfaction for serum CEA measurements has to be determined.
Study objective
The primary objective of the study is to determine 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 and in which a CEA level could be
determined reliably and that was comparable to the prior measurement sampled by
venipuncture.
Study design
The study is a prospective cohort study of 100 subjects to determine
feasibility, reliability, and satisfaction of (automated) capillary sampling
compared to venipuncture. To properly determine reliability of (automated)
capillary CEA measurements, elevated, normal, and low CEA levels need to be
evaluated under identical pre-analytical circumstances. A three armed approach
is therefore taken:
Arm A: 20 subjects with known elevated serum CEA (elevated levels)
Arm B: 60 subjects currently undergoing CRC related follow-up (normal levels)
Arm C: 20 volunteers with no known history of CRC (low levels)
Reliability of CEA measurements will be assessed for automated capillary and
lancet capillary sampling compared to venipuncture across all three arms.
Satisfaction in terms of patient reported outcomes (pain, burden, ease of use,
and preference) will be evaluated in all 100 study subjects. Feasibility of
capillary sampling at home will be assessed in Arm B only: 60 patients
undergoing CRC related follow-up. Patients in Arm B 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. A schematic overview of
the study design is provided in appendix A.
Study burden and risks
All study subjects will be asked to report on their perceived pain, burden,
ease of use, and preference of the techniques by completing a questionnaire. In
addition, patients who currently undergo CRC related follow-up will be asked to
complete automated and lancet capillary sampling at home after two regular
hospital visitations, after which they will complete the questionnaire for a
second time. There is no specific benefit associated with participation for the
study subjects. Potential risks associated with participation are low to mild
discomfort and/or temporary superficial hematomas of the skin following
venipuncture. For the volunteers in study arm C a potential risk will be
determination of an elevated CEA, after which subjects may be subjected to
other diagnostics studies to diagnose or rule out a CRC (related) cause of
elevated blood CEA.
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Dr.Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Group A:
Age >= 21 years
Histologically confirmed (metastatic) colorectal adenocarcinoma
Serum CEA >= 10 µg/L within the last 2 months determined using venipuncture
blood sampling
Group B:
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
Group C:
Age >= 21 years
No known history of colorectal adenocarcinoma
No known history of elevated serum CEA >= 5 µg/L
Exclusion criteria
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL78309.078.21 |