A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC

Not yet recruiting

• Conditions: Neutropenia; Leukocytosis; Leukopenia
• Interventions: Device: Tasso+ CBC

• Registration Number: NCT06360952
• Lead Sponsor: Tasso Inc.

Brief Summary

This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients.

Detailed Description

This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients.

The primary aim of this study is to demonstrate the agreement between capillary blood collected using the Tasso device and venous blood collected in a K2EDTA (dipotassium ethylenediaminetetraacetic acid) tube according to established sampling procedures for quantification of WBC and ANC as part of a standard CBC panel with 5-part differential.

The secondary aim of the study is to demonstrate the agreement between Tasso device and venous samples for the measurement of additional analytes evaluated as part of a standard CBC panel with 5-part differential, including PLTs, HGB, RBC, Hct, MCV, lymphocytes, monocytes, eosinophils, and basophils.

An exploratory aim of this research is to evaluate patient acceptance of the Tasso device in a diseased population.

Adverse Events (AEs) occurring up to 24 hours after use of the Tasso device will be evaluated.

Patient response to using the Tasso device will be collected via simple survey.

Study Timeline

• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Study Start: 2024-05-31
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Willing and able to provide written (or electronic) informed consent prior to study entry
2. At least 18 years of age
3. Requiring a CBC blood test as part of the patient's standard of care
4. Have abnormal laboratory results of either leukopenia, leukocytosis or neutropenia.
5. Normal skin integrity and healthy skin appearance around the capillary collection site (upper arm/shoulder area on at least one side)

Exclusion Criteria

1. Unable to give full and free consent to participate in a study due to limited capacity or risk of undue influence or coercion (including but not limited to children, prisoners, individuals with diminished decision-making capacity, illiterate or educationally disadvantaged populations) or any other individual who is unable to give full and free consent in the judgement of the investigator
2. At the determination of the treating physician, unsuitable for enrollment due to severe immunocompromised status or other comorbidities.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
leukopenia	Tasso+ CBC	Participants that have abnormal laboratory results for leukopenia. Participants will be assigned to all cohorts they have abnormal laboratory results for.
neutropenia	Tasso+ CBC	Participants that have abnormal laboratory results for neutropenia. Participants will be assigned to all cohorts they have abnormal laboratory results for.
leukocytosis	Tasso+ CBC	Participants that have abnormal laboratory results for leukocytosis. Participants will be assigned to all cohorts they have abnormal laboratory results for.

Primary Outcome Measures

Name	Time	Method
Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count	Day 1	To demonstrate agreement between capillary blood collected using the Tasso device and traditional venous blood collected using standard methods for measurement of white blood cells (WBCs), and absolute neutrophils count (ANC) as part of a CBC analysis with 5-part differential.

Secondary Outcome Measures

Name	Time	Method
Agreement between capillary and venous blood in the measurement of secondary biomarkers	Day 1	To demonstrate agreement between capillary blood collected using the Tasso device and traditional venous blood collected using standard methods for measurement of remaining CBC components including platelets (PLTs), hemoglobin (HGB), red blood cells (RBCs), hematocrit (Hct), and mean corpuscular volume (MCV), as well as differential quantification of lymphocytes, monocytes, eosinophils, and basophils.

Trial Locations

Locations (1)

Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States