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

Neutropenia Clinical Trial

Official title:

A Comparator Study of a Tasso Device to Traditional Venous Blood Sampling Methods for Complete Blood Count (CBC) With 5-part Differential in Patients With Leukemia, Lymphoma, and/or Other Blood Cell Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360952
• Other study ID #: T23-03
• Status: Not yet recruiting
• Start date: May 31, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: Tasso Inc.
• Contact: Shivani Surati
• Phone: (919) 966-7597
• Email: Shivani_Surati[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukocytosis
• Leukopenia
• Neutropenia

Intervention

Device:
• Tasso+ CBC
Novel blood collection device

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Tasso Inc.	The Leukemia and Lymphoma Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient acceptance of Tasso device	To evaluate patient acceptance of the Tasso device in a diseased population via survey responses. Survey responses will consist of a series of questions referencing the participant perception of the experience with the Tasso device using The Satisfaction Scale under the parameters of 1 through 5 (1 - Strongly Disagree through 5 - Strongly Agree) and other questions asking for participant preference in regards to the means of sample collection and location (ex. Venipuncture versus Tasso, self-collected at home or preformed at a doctor's office or clinic).	Day 1
Primary	Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count	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.	Day 1
Secondary	Agreement between capillary and venous blood in the measurement of secondary biomarkers	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.	Day 1