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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neutropenia; Leukopenia; Leukocytosis
• Intervention / Treatment: Device: Tasso+ CBC

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Shivani Surati; Phone Number: (919) 966-7597; Email: Shivani_Surati@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Lineberger Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with known blood cancers and/or blood cell disorders resulting in abnormal laboratory results for either leukopenia, leukocytosis or neutropenia will be recruited and enrolled into this study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
leukopenia; Participants that have abnormal laboratory results for leukopenia. Participants will be assigned to all cohorts they have abnormal laboratory results for.	Device: Tasso+ CBC; Novel blood collection device
leukocytosis; Participants that have abnormal laboratory results for leukocytosis. Participants will be assigned to all cohorts they have abnormal laboratory results for.	Device: Tasso+ CBC; Novel blood collection device
neutropenia; Participants that have abnormal laboratory results for neutropenia. Participants will be assigned to all cohorts they have abnormal laboratory results for.	Device: Tasso+ CBC; Novel blood collection device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tasso Inc.
• Collaborators: The Leukemia and Lymphoma Society
• Investigators: Principal Investigator: Erwin Berthier, Phd, Tasso Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: neutropenia; leukocytosis; CBC; leukopenia; Tasso
• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Agranulocytosis; Leukocyte Disorders; Cytopenia; Neutropenia; Leukopenia; Leukocytosis
• Other Study ID Numbers: T23-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes