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Trial Title:
Capillary-Venous Paired Data Collection
NCT ID:
NCT05926362
Condition:
Oncology
Conditions: Official terms:
Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Cross-Sectional
Summary:
Capillary-venous paired data collection.
Detailed description:
An iterative data collection study to continuously assess the performance of our Entia
Liberty device with cancer patients. Our device enables a full blood count from a finger
prick sample. The participants enrolled in the study will attend the study site for their
routine venepuncture blood test. Once enrolled, they will have a finger prick test
obtained by a Healthcare Professional (trained member of the clinical research team) to
be tested on an Entia Liberty device. Within 4 hours of that same participant's routine
venepuncture, a small amount of blood from the venepuncture will be also tested on a
second Entia Liberty device in the laboratory. All the results from the capillary finger
prick Liberty test, routine venepuncture blood test (gold standard reference method) and
the venous blood Liberty test will be compared against each other to regularly assess
that the improvements made on the measurement system of the device is sufficient.
Criteria for eligibility:
Study pop:
Patients who are currently receiving standard of care systemic anti-cancer therapy
(chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy
and have received at least one cycle.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age >18 years old at the time of study entry
- Currently receiving standard of care systemic anti-cancer therapy (chemotherapy,
immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has
received at least one cycle of treatment
- Scheduled to be undergoing routine venous laboratory blood tests as part of standard
of care
- Can provide written informed consent
Exclusion Criteria:
- History of haematological malignancy
- Inadequate use and understanding of the English language, requiring a translator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2023
Completion date:
September 1, 2026
Lead sponsor:
Agency:
Entia Ltd
Agency class:
Industry
Source:
Entia Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05926362
