Clinical trial NCT06360952: A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Leukopenia
Leukocytosis
Neutropenia
Keywords: leukocytosis
neutropenia
leukopenia
CBC
Tasso
Lead sponsor: Tasso Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2024-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count
timeFrame: Day 1
Secondary outcomes:
measure: Agreement between capillary and venous blood in the measurement of secondary biomarkers
timeFrame: Day 1
Other outcomes:
measure: Patient acceptance of Tasso device
timeFrame: Day 1
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Tasso Inc.
name: Erwin Berthier, Phd
role: PRINCIPAL_INVESTIGATOR
References: