Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-04-17 @ 10:12 PM
Study NCT ID:
NCT02924532
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2016-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007011', 'term': 'Hypoparathyroidism'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the presence/absence of hypoparathyroidism', 'timeFrame': 'day 1', 'description': 'hypoparathyroidism is defined as: corrected serum calcium Day 1 \\<1.90 and / or symptoms of hypocalcemia (cramps, tingling of the extremities and peri-oral) to Day 1 authenticated by a VAS score\\> 3.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypoparathyroidism']}, 'referencesModule': {'references': [{'pmid': '29594052', 'type': 'RESULT', 'citation': 'Galy-Bernadoy C, Lallemant B, Chambon G, Pham HT, Reynaud C, Alovisetti C, Bonduelle Q, Guedj AM, Lumbroso S, De Brauwere DP. Parathyroid Hormone Assays following Total Thyroidectomy: Is There a Predictive Value? Eur Thyroid J. 2018 Jan;7(1):34-38. doi: 10.1159/000484689. Epub 2017 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to establish an optimal threshold Early parathormon (PTH) assay in order to exclude hypoparathyroidism , that is to say to obtain a negative predictive value of hypoparathyroidism highest possible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Included patients underwent total thyroidectomy from 1 February 2012 to 1 December 2013 at the Nîmes University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients consecutively operated on between February 1, 2012 and December 1, 2013\n* Total thyroidectomy +/- lymphadenectomy\n* Respect of clinicobiological protocol presented above\n* The ( the ) patient ( e) was informed ( e) on the implementation of the study 's objectives, constraints and patient rights\n* The ( the ) patient ( e) is under ( e) at least 18 years\n\nExclusion Criteria:\n\n* The ( the ) patient ( e) is under guardianship, curatorship or under guard saves justice\n* It is not possible to give to ( the ) patient ( e) informed information\n* History of cervical radiotherapy\n* Previous history of dysfunction of the parathyroid glands\n* Previous history of surgery of the parathyroid glands\n* A history of kidney failure or hepatocellular\n* History of osteomalacia or Paget's disease\n* unhealed cancer antecedent\n* History of sarcoidosis"}, 'identificationModule': {'nctId': 'NCT02924532', 'briefTitle': 'Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Diagnostic Value of Immediate Postoperative Dose of Parathyroid Hormone as a Marker for the Occurrence of Hypoparathyroidism After Total Thyroidectomy: A Retrospective Observational Study', 'orgStudyIdInfo': {'id': 'LOCAL/2014/BL-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with total thiroidectomy', 'interventionNames': ['Biological: immediate post operative bioassay of Parathyroid Hormone']}], 'interventions': [{'name': 'immediate post operative bioassay of Parathyroid Hormone', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Patients with total thiroidectomy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}