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

NCT06360952 | Not Yet Recruiting FDA Device

• 1 other identifier: T23-03
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukopenia; Leukocytosis; Neutropenia

Keywords

leukocytosis; neutropenia; leukopenia; CBC; Tasso

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Agreement between capillary and venous blood in the measurement of secondary biomarkers

  Day 1

Other Outcomes (1)

• Patient acceptance of Tasso device

  Day 1

Study Arms (3)

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

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

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

Interventions

Tasso+ CBC DEVICE

Novel blood collection device

leukocytosis; leukopenia; neutropenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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
• At the determination of the treating physician, unsuitable for enrollment due to severe immunocompromised status or other comorbidities.

Sponsors & Collaborators

• Tasso Inc.: lead
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Leukopenia; Leukocytosis; Neutropenia

Condition Hierarchy (Ancestors)

Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Agranulocytosis

Study Officials

• Erwin Berthier, Phd

  Tasso Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shivani Surati

CONTACT

(919) 966-7597; Shivani_Surati@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: April 11, 2024
• Study Start: May 31, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)