Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| leukopenia | Participants that have abnormal laboratory results for leukopenia. Participants will be assigned to all cohorts they have abnormal laboratory results for. |
| |
| leukocytosis | Participants that have abnormal laboratory results for leukocytosis. Participants will be assigned to all cohorts they have abnormal laboratory results for. |
| |
| neutropenia | Participants that have abnormal laboratory results for neutropenia. Participants will be assigned to all cohorts they have abnormal laboratory results for. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasso+ CBC | Device | Novel blood collection device |
|
| 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 |
| 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. |
| 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). |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivani Surati | Contact | (919) 966-7597 | Shivani_Surati@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erwin Berthier, Phd | Tasso Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007970 | Leukopenia |
| D007964 | Leukocytosis |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1 |
| Day 1 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000380 | Agranulocytosis |