Transplantation Drugs StabilityNCT05274308
Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
An observational study of Transplantation Drugs Stability, run by Thermo Fisher Scientific Oy at 1 site in Italy.
Trial summary
This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation Drugs Stability
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 7 Feb 2022to 26 Jul 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: Subject's using following immunosuppressants drugs accordingly with organ transplantation 1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A 2. Kidney or liver transplant patient using everolimus 3. Kidney transplant patient using sirolimus
Who may be able to join
- Age ≥18 years
- Ability to sign informed consent form
- At least one of the following
- Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
- Kidney or liver transplant patient using everolimus
- Kidney transplant patient using sirolimus
Who cannot join
- Inability to provide informed consent
- Pregnancy or breastfeeding
- Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica
Turin, 10126
About this study
Official title: Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.
To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.
Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.
- Conditions
- Transplantation Drugs Stability
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling from all eligible transplantation patients according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| Patient blood sample collection | 30 mL of whole blood collected from eligible patients in one sampling Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance criteria for claiming the patient samples storage stability
Stability of cyclosporine A, tacrolimus, everolimus and sirolimus in patient whole blood samples will be tested at +15-25°C up to 4 days, at +2-8°C up to 15 days and at -20±5°C up to 31 days. Relative bias at each time point to T0 baseline is calculated for each patient sample separately. The grand average relative bias across all samples, and the associated 95% confidence interval, must be within -15% and +15%.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start7 Feb 2022
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation Drugs StabilityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thermo Fisher Scientific Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Sanna Anttonen, Study director, Thermo Fisher Scientific, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274308
- Sponsor's protocol ID
- CA1803-STSS-PRO
- Status last verified
- Oct 2022
- First submitted
- 1 Mar 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
- ClinicalTrials.gov ID
- NCT05274308
- Acronym / sponsor ID
- CA1803-STSS-PRO
- Conditions
- Transplantation Drugs Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Thermo Fisher Scientific OyIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 10 Mar 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.
This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.
To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.
Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient blood sample collection | – | Procedure: Blood sampling30 mL of whole blood collected from eligible patients in one sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject's using following immunosuppressants drugs accordingly with organ transplantation 1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A 2. Kidney or liver transplant patient using everolimus 3. Kidney transplant patient using sirolimus
Key inclusion criteria (6 listed)
- Age ≥18 years
- Ability to sign informed consent form
- At least one of the following
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Pregnancy or breastfeeding
- Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort
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 |
|---|---|---|
| Blood samplingBlood sampling from all eligible transplantation patients according to the protocol | Procedure or surgery | Patient blood sample collection |
Primary outcome
Acceptance criteria for claiming the patient samples storage stability
Time frame: 5 months
Stability of cyclosporine A, tacrolimus, everolimus and sirolimus in patient whole blood samples will be tested at +15-25°C up to 4 days, at +2-8°C up to 15 days and at -20±5°C up to 31 days. Relative bias at each time point to T0 baseline is calculated for each patient sample separately. The grand average relative bias across all samples, and the associated 95% confidence interval, must be within -15% and +15%.
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 7 Oct 2022.
- Individual participant dataSharing planned: No
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.
Sanna Anttonen study director
Thermo Fisher Scientific, 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 Transplantation Drugs Stability, run by Thermo Fisher Scientific Oy at 1 site in Italy.
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 3 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 7 Oct 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 Italy. 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?
Acceptance criteria for claiming the patient samples storage stability (time frame: 5 months). 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 7 Oct 2022.