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Capillary-Venous Paired Collection

NCT ID: NCT06183151

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-05-31

Brief Summary

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This study is recruiting participants to donate 2 capillary blood samples to be tested on the investigational system. At the same time, remnant routine blood samples used for Complete Blood Count (CBC) testing from the same participants will be tested on the investigation system. The participants' routine 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 remnant blood samples on the investigational 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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Participants

All participants to undergo the same study method. Where all participants are to donate capillary blood to complete 2 tests on the investigational system and the remnant blood sample from routine CBC testing will also be tested on the investigational system. The routine CBC results will be compared to the results obtained by the investigational system.

Entia Liberty System

Intervention Type DEVICE

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Interventions

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Entia Liberty System

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Intervention Type DEVICE

Eligibility Criteria

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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
* Scheduled to be undergoing routine CBC blood tests as part of standard of care
* Can provide written informed consent
* In the Investigator's opinion, is able and willing to comply with all study requirements

Exclusion Criteria

* History or current diagnosis of hematological malignancy (including bone and lymph)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Entia Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CAVE-USA

Identifier Type: -

Identifier Source: org_study_id