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OpenTrials
Completed

NCT Number: NCT05274308

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.

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Key information

Conditions

Transplantation Drugs Stability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica

Turin, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

blood sampling

Procedure

Blood sampling from all eligible transplantation patients according to the protocol

Primary outcomes

  1. 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%.

Sponsors and collaborators

Lead sponsor

Thermo Fisher Scientific Oy

Industry

Collaborators

  • ICON plc

Registry information

Official study title

Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2022
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.