LeukopeniaNCT06360952
A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC
An observational study of Leukopenia and Leukocytosis, run by Tasso Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukopenia, Leukocytosis, Neutropenia
- What is being tested?
- Tasso+ CBC
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
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
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.
Read the 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.
- Conditions
- Leukopenia, Leukocytosis, Neutropenia
- Being tested
- Tasso+ CBC
- Keywords
- leukocytosis, neutropenia, leukopenia, CBC, Tasso
- Medical subject headings
- Leukopenia, Leukocytosis, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasso+ CBCDevice
Novel blood collection device
| Study group | Role | What they receive |
|---|---|---|
| leukopenia | Participants that have abnormal laboratory results for leukopenia. Participants will be assigned to all cohorts they have abnormal laboratory results for. Receives: 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. Receives: 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. Receives: Device: Tasso+ CBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start31 May 2024 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasso Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Responsible party
- Sponsor
- Investigators
- Erwin Berthier, Phd, Principal investigator, Tasso Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360952
- Sponsor's protocol ID
- T23-03
- Status last verified
- May 2024
- First submitted
- 2 Feb 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06360952
- Acronym / sponsor ID
- T23-03
- Conditions
- Leukopenia, Leukocytosis, Neutropenia
- Keywords
- leukocytosis, neutropenia, leukopenia, CBC, Tasso
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tasso Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society
- Study start
- 31 May 2024 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| leukopenia | – | Device: Tasso+ CBCParticipants that have abnormal laboratory results for leukopenia. Participants will be assigned to all cohorts they have abnormal laboratory results for. |
| leukocytosis | – | Device: Tasso+ CBCParticipants that have abnormal laboratory results for leukocytosis. Participants will be assigned to all cohorts they have abnormal laboratory results for. |
| neutropenia | – | Device: Tasso+ CBCParticipants that have abnormal laboratory results for neutropenia. Participants will be assigned to all cohorts they have abnormal laboratory results for. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasso+ CBCNovel blood collection device | Device | leukocytosis, leukopenia, neutropenia |
Primary outcome
Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count
Time frame: Day 1
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.
1 secondary outcome
Agreement between capillary and venous blood in the measurement of secondary biomarkers
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erwin Berthier, Phd principal investigator
Tasso Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukopenia and Leukocytosis, run by Tasso Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shivani Surati ((919) 966-7597, Shivani_Surati@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.