Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 6:57 PM
Study NCT ID:
NCT05274308
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2022-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood samples in K2 EDTA tubes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2022-03-01', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptance criteria for claiming the patient samples storage stability', 'timeFrame': '5 months', 'description': '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%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transplantation Drugs Stability']}, 'descriptionModule': {'briefSummary': '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.\n\nTo 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.\n\nStudy subjects will undergo one venous sample collection where 30 mL of blood is drawn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Subject's using following immunosuppressants drugs accordingly with organ transplantation\n\n1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A\n2. Kidney or liver transplant patient using everolimus\n3. Kidney transplant patient using sirolimus", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years\n2. Ability to sign informed consent form\n3. At least one of the following\n\n 1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A\n 2. Kidney or liver transplant patient using everolimus\n 3. Kidney transplant patient using sirolimus\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Pregnancy or breastfeeding\n3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort"}, 'identificationModule': {'nctId': 'NCT05274308', 'briefTitle': 'Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples', 'organization': {'class': 'INDUSTRY', 'fullName': 'Thermo Fisher Scientific Oy'}, 'officialTitle': 'Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples', 'orgStudyIdInfo': {'id': 'CA1803-STSS-PRO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient blood sample collection', 'description': '30 mL of whole blood collected from eligible patients in one sampling', 'interventionNames': ['Procedure: Blood sampling']}], 'interventions': [{'name': 'Blood sampling', 'type': 'PROCEDURE', 'description': 'Blood sampling from all eligible transplantation patients according to the protocol', 'armGroupLabels': ['Patient blood sample collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'overallOfficials': [{'name': 'Sanna Anttonen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Thermo Fisher Scientific, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thermo Fisher Scientific Oy', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ICON plc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}