Elevated Alanine Transaminase (ALT)ARRRNCT05259618
ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
An observational study of Elevated Alanine Transaminase (ALT), run by Tasso Inc. at 3 sites in United States.
Trial summary
A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Alanine Transaminase (ALT)
- What is being tested?
- Tasso+ SST
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Feb 2021to Nov 2022
- 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 an ALT > 3 X upper limit of normal
Who may be able to join
- Subject must be willing and able to provide written informed consent prior to study entry
- Subject is ≥ 18 years of age.
- Subject must meet the following criterion:
- known recent history of liver function abnormality and requiring follow-up Liver tests (including ALT>3XULN)
- Subject must be willing and able to adhere to the assessments, study schedule, prohibitions and restrictions as described in the protocol.
- Patients may be on any treatment / therapeutic clinical trial as indicated by treating physician
Who cannot join
- Pregnant or nursing female by self-report.
- Presents with abnormal skin integrity or atypical skin health within the areas to be tested (upper shoulders).
- Subjects who have applied lotion to the skin on the shoulder the day of the visit.
- Patients with hepatic encephalopathy
- Vulnerable populations (children, prisoners, pregnant women, participants with diminished decision-making capacity, illiterate populations, educationally disadvantaged populations).
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Don Morie, 303-724-7236, don.morie@cuanschutz.edu
Clayton Smith, MD
- Recruiting
EvergreenHealth Research
Kirkland, Washington, 98034
Conner Bentley, 425-899-5385, CCBentley@evergreenhealth.com
Diego Lopez de Castilla, MD
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10017
Amin Yaqubie, 646-888-4332, yaqubiea@mskcc.org
James J Harding, MD
About this study
Official title: Project ARRR, ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).
Read the detailed description
This is a prospective, non-blinded, multi-center study to be conducted within the USA. This study will consist of a single arm. Blood will be drawn from each subject, using two different collection methods: the Tasso+ device and the conventional venipuncture method. The results will be compared assess correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Participants can complete up to 3 visits and will include self-collected blood samples using the Tasso+ device at home on the day of visit 2 and visit 3.
- Conditions
- Elevated Alanine Transaminase (ALT)
- Being tested
- Tasso+ SST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasso+ SSTOther
Also called Tasso+
alternative site blood sample collection.
| Study group | Role | What they receive |
|---|---|---|
| Patients with elevated alanine transaminase (ALT) | patients with alanine transaminase (ALT) > 3x upper limit of normal (ULN). Receives: Other: Tasso+ SST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous and Tasso+ blood sample comparison for ALT
Correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for ALT, AST and total bilirubin, quantified using a Roche Cobas 8000/c702 or an equivalent analyzer.
Measured: through study completion, an average of 1 Year and 6 Months
Secondary outcomes (2)
Venous and Tasso+ blood sample comparison for additional analytes
Correlation of additional analytes including Total Protein, Albumin, Glucose, Sodium, Potassium, Chloride, Magnesium, Calcium, Phosphorus, Enzymatic Creatinine and alkaline Phosphatase (ALP) in blood collected with the Tasso+ device and by venipuncture in a Vacutainer (SST, Red Top tube) analyzed using a Roche Cobas 8000/c702 or an equivalent analyzer or an equivalent analyzer.
Measured: through study completion, an average of 1 Year and 6 Months
To collect patient experience with the Tasso blood collection
To collect patient experience with the Tasso blood collection utilizing a brief survey aimed at understanding patient experience and preferences on the use and adoption of Tasso+ to collect a blood sample independently (with the help of a caregiver if needed), outside of the clinic.
Measured: through study completion, an average of 1 Year and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start16 Feb 2021
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elevated Alanine Transaminase (ALT)Studies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasso Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259618
- Sponsor's protocol ID
- TALT01-20
- Acronym
- ARRR
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wickremsinhe E, Fantana A, Berthier E, Quist BA, Lopez de Castilla D, Fix C, Chan K, Shi J, Walker MG, Kherani JF, Knoderer H, Regev A, Harding JJ. Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of Abnormal Liver Chemistry. J Appl Lab Med. 2023 May 4;8(3):535-550. doi: 10.1093/jalm/jfac127.
PubMed 36533519
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ARRR, ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
- ClinicalTrials.gov ID
- NCT05259618
- Acronym / sponsor ID
- ARRR / TALT01-20
- Conditions
- Elevated Alanine Transaminase (ALT)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tasso Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 28 Feb 2022 (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.
A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).
Detailed description
This is a prospective, non-blinded, multi-center study to be conducted within the USA. This study will consist of a single arm. Blood will be drawn from each subject, using two different collection methods: the Tasso+ device and the conventional venipuncture method. The results will be compared assess correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Participants can complete up to 3 visits and will include self-collected blood samples using the Tasso+ device at home on the day of visit 2 and visit 3.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with elevated alanine transaminase (ALT) | – | Other: Tasso+ SSTpatients with alanine transaminase (ALT) > 3x upper limit of normal (ULN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an ALT > 3 X upper limit of normal
Key inclusion criteria (6 listed)
- Subject must be willing and able to provide written informed consent prior to study entry
- Subject is ≥ 18 years of age.
- Subject must meet the following criterion:
- known recent history of liver function abnormality and requiring follow-up Liver tests (including ALT>3XULN)
- Subject must be willing and able to adhere to the assessments, study schedule, prohibitions and restrictions as described in the protocol.
Key exclusion criteria (5 listed)
- Pregnant or nursing female by self-report.
- Presents with abnormal skin integrity or atypical skin health within the areas to be tested (upper shoulders).
- Subjects who have applied lotion to the skin on the shoulder the day of the visit.
- Patients with hepatic encephalopathy
- Vulnerable populations (children, prisoners, pregnant women, participants with diminished decision-making capacity, illiterate populations, educationally disadvantaged populations).
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+ SSTAlso: Tasso+alternative site blood sample collection. | Other | Patients with elevated alanine transaminase (ALT) |
Primary outcome
Venous and Tasso+ blood sample comparison for ALT
Time frame: through study completion, an average of 1 Year and 6 Months
Correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for ALT, AST and total bilirubin, quantified using a Roche Cobas 8000/c702 or an equivalent analyzer.
2 secondary outcomes
Venous and Tasso+ blood sample comparison for additional analytes
Time frame: through study completion, an average of 1 Year and 6 Months
To collect patient experience with the Tasso blood collection
Time frame: through study completion, an average of 1 Year and 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 36533519Wickremsinhe E, Fantana A, Berthier E, Quist BA, Lopez de Castilla D, Fix C, Chan K, Shi J, Walker MG, Kherani JF, Knoderer H, Regev A, Harding JJ. Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of Abnormal Liver Chemistry. J Appl Lab Med. 2023 May 4;8(3):535-550. doi: 10.1093/jalm/jfac127.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elevated Alanine Transaminase (ALT), run by Tasso Inc. at 3 sites 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 6 inclusion and 5 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 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Brook Quist ((206) 822-4186 ext. 1004, brook@tassoinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous and Tasso+ blood sample comparison for ALT (time frame: through study completion, an average of 1 Year and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259618, which also lists 1 linked publication.
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 28 Feb 2022.