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
Verified date | May 2024 |
Source | Tasso Inc. |
Contact | Shivani Surati |
Phone | (919) 966-7597 |
Shivani_Surati[@]med.unc.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Tasso Inc. | The Leukemia and Lymphoma Society |
United States,
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 |
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