Clinical trial · Observational
Capillary-Venous Paired Collection
CApillary-VEnous Paired Collection (CAVE)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment Paused for data review
Summary
Brief summary (as posted)
This study is recruiting participants to donate 3 capillary blood samples to be tested on the investigational system and venous blood to be tested on a comparator system. At the some sites, additional venous blood samples from the same participants will be tested on the investigation system. The participants' CBC results analyzed on the gold standard laboratory analyzer (comparator) will be collected and compared against the results obtained from the testing of capillary blood samples and venous blood samples on the investigational system. At certain sites, the usability of the investigational system is observed to evaluate the usability of the system. The participants' involvement in the study is only for the duration of collecting the blood samples. No follow-up is anticipated. The results from the investigational system is for research use only and will not inform or change the participants' treatment or care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Medical Device Performance | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entia Liberty System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants
- description
- All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 3 tests on the investigational system and a comparator venous sample for testing on a comparator system. For certain sites, an additional venous sample will also be tested on the investigational system. The venous CBC results from the comparator system will be compared to the results of both capillary and venous specimens obtained by the investigational system.
- interventionNames
- Device: Entia Liberty System
Primary outcomes (5)
- measure
- To validate the measurement performance of the investigational system
- timeFrame
- through study completion, estimated 6 months
- description
- The difference between the measured parameters of the comparator and investigational system will provide the bias (and therefore also the % bias) of the investigational system, which will be checked against pre-determined acceptance criteria.
- measure
- To validate the measurement performance of the investigational system (regression)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Informed Consent signed by the subject * Age ≥21 years old at the time of study entry * Currently receiving standard-of-care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and/or targeted therapy) for solid organ malignancy * Scheduled to be undergoing routine venous laboratory blood tests as part of the standard of care OR willing to undergo a research-specific venous draw to obtain a complete/full blood count (CBC/FBC) Exclusion Criteria: * History or current diagnosis of hematological malignancy (including bone and lymph) * Patients who self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty, and who do not have a carer who can assist them. * Patients who have had prior experience using Liberty * Inadequate use and understanding of the English language, requiring a translator Carer eligibility: * Age ≥ 21 years old at the time of study entry * Can provide written informed consent * Do NOT self-report disabilities or issues with their eyesight, hearing or dexterity that they believe will preclude the use of Liberty * Have NOT had prior experience using Liberty * Adequate use and understanding of the English language; NOT requiring a translator
References
Publications (0)
Data not yet available