Validate Volumetric Absorptive Microsampling (VAMS) AssayVAMSNCT04810143
Tacrolimus Microsampling
A study testing Mitra Microsampler in people with Validate Volumetric Absorptive Microsampling (VAMS) Assay, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Validate Volumetric Absorptive Microsampling (VAMS) Assay
- What is being tested?
- Mitra Microsampler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 28 Jul 2022
- Phase
- Interventional
- 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 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age
- Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits
- Aim 2: outpatient
- Currently taking tacrolimus
Who cannot join
- Non-English-speaking patients
- Unable to access overnight delivery services (Aim 2 only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: Development of an Assay for Tacrolimus Blood Trough Measurement in Pediatric Heart Transplant Patients Using Volumetric Absorptive Microsampling (VAMS) and Stable-Labeled Isotope Dilution Tandem Mass Spectrometry.
This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.
- Being tested
- Mitra Microsampler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitra MicrosamplerDevice
an FDA Class I medical device for direct specimen collection of blood or other biological fluids
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 | Experimental | All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits. A convenience sample of 25 inpatient samples will be collected for Aim 1. Although the assay developed by the MSCF will be validated for accuracy, the purpose of Aim 1 is to test "real world" application of the Mitra Microsampler tubes against the gold standard of blood collected by venipuncture in a controlled setting. To accomplish this, consecutive inpatient heart transplant patients will be enrolled. That sample will be collected at the same time (+/- 15 minutes) as a clinically-indicated, appropriately-timed venipuncture for measurement of a tacrolimus trough and prior to the subject taking tacrolimus so as to represent a trough. Receives: Device: Mitra Microsampler |
| Aim 2 | Experimental | Outpatient. A convenience sample of 25 outpatients collecting 1-2 samples will be collected for Aim 2. For those who agree to participate, the parent/patient will be taught by a member of the team on how to use the Microsampler to collect blood from a finger stick. They will be provided with a kit for collection of up to 2 samples and will also be provided with appropriate shipping materials to return samples to CCHMC. Participants will then be instructed to collect a sample in the Mitra Microsampler via fingerstick. In addition to the process of collecting the sample in Aim 2, appropriately-aged participants and/or families will be asked to fill out a brief survey regarding sample collection. This will include questions about the ease or difficulty of performing the steps and tolerability of the procedure relative to past experiences with values obtained by venipuncture. Receives: Device: Mitra Microsampler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of +/-10%
A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.
Measured: 18-24 months from start of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start7 Oct 2019
- Primary completion3 Jan 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validate Volumetric Absorptive Microsampling (VAMS) AssayStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas C Ryan, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810143
- Sponsor's protocol ID
- 2019-0943
- Acronym
- VAMS
- Status last verified
- Dec 2022
- First submitted
- 17 Mar 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Assay for Tacrolimus Blood Trough Measurement in Pediatric Heart Transplant Patients Using Volumetric Absorptive Microsampling (VAMS) and Stable-Labeled Isotope Dilution Tandem Mass Spectrometry.
- ClinicalTrials.gov ID
- NCT04810143
- Acronym / sponsor ID
- VAMS / 2019-0943
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 22 Mar 2021 (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 is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | Experimental | Device: Mitra MicrosamplerAll patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits. A convenience sample of 25 inpatient samples will be collected for Aim 1. Although the assay developed by the MSCF will be validated for accuracy, the purpose of Aim 1 is to test "real world" application of the Mitra Microsampler tubes against the gold standard of blood collected by venipuncture in a controlled setting. To accomplish this, consecutive inpatient heart transplant patients will be enrolled. That sample will be collected at the same time (+/- 15 minutes) as a clinically-indicated, appropriately-timed venipuncture for measurement of a tacrolimus trough and prior to the subject taking tacrolimus so as to represent a trough. |
| Aim 2 | Experimental | Device: Mitra MicrosamplerOutpatient. A convenience sample of 25 outpatients collecting 1-2 samples will be collected for Aim 2. For those who agree to participate, the parent/patient will be taught by a member of the team on how to use the Microsampler to collect blood from a finger stick. They will be provided with a kit for collection of up to 2 samples and will also be provided with appropriate shipping materials to return samples to CCHMC. Participants will then be instructed to collect a sample in the Mitra Microsampler via fingerstick. In addition to the process of collecting the sample in Aim 2, appropriately-aged participants and/or families will be asked to fill out a brief survey regarding sample collection. This will include questions about the ease or difficulty of performing the steps and tolerability of the procedure relative to past experiences with values obtained by venipuncture. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age
- Currently taking tacrolimus
Key exclusion criteria (2 listed)
- Non-English-speaking patients
- Unable to access overnight delivery services (Aim 2 only)
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 |
|---|---|---|
| Mitra Microsampleran FDA Class I medical device for direct specimen collection of blood or other biological fluids | Device | Aim 1, Aim 2 |
Primary outcome
Accuracy of +/-10%
Time frame: 18-24 months from start of enrollment
A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Undecided
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.
Thomas C Ryan principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitra Microsampler in people with Validate Volumetric Absorptive Microsampling (VAMS) Assay, run by Children's Hospital Medical Center, Cincinnati 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 4 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: finished, as of the sponsor's last update on 20 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of +/-10% (time frame: 18-24 months from start of enrollment). 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 20 Dec 2022.