Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

NCT05274308 | Completed

• 1 other identifier: CA1803-STSS-PRO
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient blood sample collection

30 mL of whole blood collected from eligible patients in one sampling

Procedure: Blood sampling

Interventions

Blood sampling PROCEDURE

Blood sampling from all eligible transplantation patients according to the protocol

Patient blood sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thermo Fisher Scientific Oy: lead
• ICON plc: collaborator

Study Sites (1)

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

Turin, 10126, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood samples in K2 EDTA tubes

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sanna Anttonen

  Thermo Fisher Scientific, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: February 7, 2022
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)