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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadionâ„¢ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadionâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient blood sample collection | 30 mL of whole blood collected from eligible patients in one sampling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Procedure | Blood sampling from all eligible transplantation patients according to the protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | 5 months |
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Inclusion Criteria:
Age ≥18 years
Ability to sign informed consent form
At least one of the following
Exclusion Criteria:
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Subject's using following immunosuppressants drugs accordingly with organ transplantation
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| Name | Affiliation | Role |
|---|---|---|
| Sanna Anttonen | Thermo Fisher Scientific, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica | Turin | 10126 | Italy |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Whole blood samples in K2 EDTA tubes
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |