Everolimus/Sirolimus assay

Principal Investigator: Thomas Chaly
Keywords: Transplant , immunosuppression , Surgery Department: Liver Transplant Program
IRB Number: 00088569 Co Investigator:  
Specialty: Transplant Surgery, Transplant Surgery
Sub Specialties: Kidney Transplant,
Recruitment Status: Not yet recruiting

Contact Information

Heather Thiesset
heather.thiesset@hsc.utah.edu
801-581-5318

Brief Summary

Within this study, samples from patients under treatment with the mTOR inhibitors
Sirolimus or Everolimus will be collected. These samples will be used in the corresponding
performance evaluation study of the respective Roche immunoassays (for corresponding
study numbers see section 1.1) and the results of this evaluation will be used for premarket
notification in the US.
 
The study is planned in accordance with the principles of evidence-based medicine using
the PICO criteria.
The PICO criteria applied to this study:
· P: Patient Population Definition: Male or female subject ≥ 22 years treated with
Sirolimus or Everolimus to prevent graft rejection following an organ
transplantation.
· I: Index/Marker/Product to be studied: Elecsys Sirolimus assay and Elecsys
Everolimus assay.
· C: Comparator: Competitor systems (Abbott Architect (SRL); QMS Everolimus
Thermo Fisher (EVL)). Validated LC-MS/MS methods will be used as reference
methods.
· O: Outcome: Agreement to competitor systems (see above) and comparability to
LC-MS/MS reference methods.
The comparison is NOT part of this sample collection. The comparison is part of the
separate performance evaluation and its protocols (for corresponding study numbers see
section 1.1).

Inclusion Criteria

Inclusion Criteria
· If Informed Consent is required by the IRB/EC, it was signed prior to sample
collection.
· The patient is 22 years or older.
· After transplantation the patient is treated with Sirolimus (past kidney transplant)
or Everolimus (past kidney, past liver transplant).
· A minimum sample volume of 3.5 mL is available (Sample type: K2 or K3 EDTA
whole blood). Samples are collected and stored according to the protocol.
· Concentration (last value measured) of Sirolimus or Everolimus is approximately
between 1.5-30 ng/mL for Sirolimus and 1-30 ng/mL for Everolimus.

Exclusion Criteria

Exclusion Criteria
· Known pregnancy.
· Currently breast feeding.
· The patient is treated with Sirolimus or Everolimus for any other indication.
· Transplant recipients receiving Sirolimus and Everolimus therapy subsequently or
vice versa.