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

Sponsor
Thermo Fisher Scientific Oy (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05274308
Collaborator
ICON plc (Industry)
52
Enrollment
1
Location
3.7
Anticipated Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood sampling

Study Design

Study Type:
Observational
Anticipated Enrollment :
52 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
Actual Study Start Date :
Feb 7, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Patient blood sample collection

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

Procedure: Blood sampling
Blood sampling from all eligible transplantation patients according to the protocol

Outcome Measures

Primary Outcome Measures

  1. Acceptance criteria for claiming the patient samples storage stability [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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age ≥18 years

  2. Ability to sign informed consent form

  3. At least one of the following

  4. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A

  5. Kidney or liver transplant patient using everolimus

  6. Kidney transplant patient using sirolimus

Exclusion Criteria:

  1. Inability to provide informed consent

  2. Pregnancy or breastfeeding

  3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort

Contacts and Locations

Locations

Site City State Country Postal Code
1 AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica Turin Italy 10126

Sponsors and Collaborators

  • Thermo Fisher Scientific Oy
  • ICON plc

Investigators

  • Study Director: Sanna Anttonen, Thermo Fisher Scientific, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thermo Fisher Scientific Oy
ClinicalTrials.gov Identifier:
NCT05274308
Other Study ID Numbers:
  • CA1803-STSS-PRO
First Posted:
Mar 10, 2022
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 28, 2022