Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-17 @ 8:13 AM
Study NCT ID:
NCT05151120
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2021-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, '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_WITHOUT_DNA', 'description': '1 sample during routine venepuncture of 49 mL blood collection (7 x 7mL)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-05-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjet included', 'timeFrame': 'through study completion, an average of 18 months', 'description': 'The primary objective is to collect 100 blood samples that distributed into the followings groups:\n\nGROUP A: Hyperthyroid (N = 30) A1: 10 patients with suppressed TSH, around 0.01 mIU/L A2: 10 patients with TSH values between 0.01 - 0.1 mIU/L A3: 10 patients with TSH values between 0.1 - 0.4 mIU/L\n\nGROUP B: Euthyroid (N = 30) Patients (under treatment) with TSH values between 0.4 - 4 mIU/L\n\nGROUP C: Hypothyroid (N = 40) C1: 20 patients with TSH values between 4 - 50 mIU/L C2: 20 patients with TSH values \\> 50 mIU/L up to 100 mIU/L.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Sample collection', 'TSH results harmonisation', 'IVD-manufacturers', 'Reference intervals', 'Results harmonisation'], 'conditions': ['Thyroid Disorders', 'Thyroid Stimulating; Hormone, C']}, 'descriptionModule': {'briefSummary': 'Given the prevalence and gravity of thyroid disorders, timely diagnosis, initiation, and monitoring of therapy are important to restrict the impact of the disease on public health. Measurement of serum thyroid stimulating hormone (TSH) concentrations is an indispensable tool to confirm the disease and clinical management.\n\nReference intervals (RI) reported along with the laboratory data are an integral part of the interpretation process. Since many laboratory measurements are not yet comparable, RIs are typically established for each assay and are considered assay-specific. In this context, physicians who request test results from different laboratories are faced with challenges owing to different RIs. Assay-specific RIs are also problematic for patients who are seen by different doctors/different countries and more generally, assay-specific measurement results limit the development of modern public health standards.\n\nParamount to the goal of using common RIs is the establishment of metrological traceability of in vitro diagnostic (IVD) medical devices-also called standardization. As the International Federation of Clinical Chemistry (IFCC) Committee for Standardization of Thyroid Function Tests (C-STFT) members, the investigators decided to focus efforts on immunoassays for TSH in partnership with the IVD industry.\n\nAlthough a reference measurement procedure existed for free thyroxine, the investigators considered this option for TSH unlikely and developed a pragmatic approach to harmonization rather than standardization.\n\nHarmonization is important in order to guarantee comparability of results obtained in different laboratories. The harmonization process is conducted by assigning target values to a large set of samples, based on the results obtained by as many IVD-manufacturers as possible (ref 2). Important here is the fact that these samples must cover the full measuring range of a TSH assay, and so it is necessary to include samples from people with thyroid disease.\n\nThe primary objective of the study is the constitution of blood samples collection from patients with thyroid disorders in order to harmonize several commercially available immunoassays used for the determination of thyroid hormone concentrations in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruitment will be performed from the clinical cohort of thyroid disorder patients followed at the Hospices Civils de Lyon Hospital.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Body weight ≥ 62 kg\n* With a thyroid disorder (with high, low or normal TSH levels)\n* Competent to give non opposition after information\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Those individuals previously enrolled into this clinical study\n* Individuals diagnosed with a severe non-thyroidal illness at physician's appreciation. Defined as a state of dysregulation where levels of T3, T4, free triiodothyronine (FT3) and/or free thyroxine (FT4) are abnormal although the Thyroid gland does not appear to be dysfunctional. In practice, non-thyroidal illness (NTI) is reported to be usually associated with critical illness or starvation. Examples: chronic renal failure, liver cirrhosis, advanced (active) malignancy, sepsis, trauma, prolonged fasting or starvation, heart failure, Myocardial infarction (MI), and any psychiatric disorder.\n* Pregnancy - please note that pregnancy test is not needed, a declaration is sufficient. The inclusion of a sample from a woman with an unidentified pregnancy will not jeopardize the study.\n* Patient under guardianship and under legal protection"}, 'identificationModule': {'nctId': 'NCT05151120', 'acronym': 'IFCC-TSH', 'briefTitle': 'Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Harmonization of Thyroid-stimulating Hormone Immunoassays Reagents - Blood Collection From Patients With Thyroid Disorders', 'orgStudyIdInfo': {'id': '69HCL21_0806'}, 'secondaryIdInfos': [{'id': '2021-A02187-34', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A: Hyperthyroid', 'description': '30 patients will be included and divided into three categories: A1: 10 patients with suppressed TSH, around 0.01 milli-international unit/liter (mIU/L) A2: 10 patients with TSH values between 0.01 - 0.1 mIU/L A3: 10 patients with TSH values between 0.1 - 0.4 mIU/L', 'interventionNames': ['Biological: blood sample']}, {'label': 'Group B: Euthyroid', 'description': '30 Patients (under treatment) with TSH values between 0.4 - 4 mIU/L will be included', 'interventionNames': ['Biological: blood sample']}, {'label': 'GROUP C: Hypothyroid', 'description': '40 patients will be included and divided into two categories: C1: 20 patients with TSH values between 4 - 50 mIU/L C2: 20 patients with TSH values \\> 50 mIU/L up to 100 mIU/L. Even distribution (if possible).', 'interventionNames': ['Biological: blood sample']}], 'interventions': [{'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': 'In practice the only intervention of the study is 49 mL extra blood along with the blood draw that is already planned for diagnosis/follow-up', 'armGroupLabels': ['GROUP C: Hypothyroid', 'Group A: Hyperthyroid', 'Group B: Euthyroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69 677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'ABEILLON Juliette, MD', 'role': 'CONTACT', 'email': 'juliette.abeillon@chu-lyon.fr', 'phone': '04 72 11 93 01', 'phoneExt': '+33'}, {'name': 'ABEILLON Juliette, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service D'endocrinologie - Hôpital Louis Pradel - Hospices Civils de Lyon", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69 677', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JANIER Marc, MD, PhD', 'role': 'CONTACT', 'email': 'marc.janier@chu-lyon.fr', 'phone': '04.72.11.02.50', 'phoneExt': '+33'}, {'name': 'JANIER Marc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Service de Médecine Nucléaire - Hôpital Louis Pradel - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'RAVEROT Véronique, MD', 'role': 'CONTACT', 'email': 'veronique.raverot@chu-lyon.fr', 'phone': '04.72.35.74.61', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}