Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT06157632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients with thyoid nodules that will do thyriodectomy'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules', 'timeFrame': 'Two year', 'description': 'Use of serum thyroglobulin to differentiate between different thyroid nodules preoperoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Level of Thyrogobulin in Different Thyroid Nodules']}, 'descriptionModule': {'briefSummary': 'Role of preoperative serum thyroglobulin level to differentiate between different thyroid nodules', 'detailedDescription': 'Incidence of thyroid nodules varies according to the methods of diagnosis, 4-7% by palpation and 17-67% by high resolution ultrasound.\n\nThe gold standard of diagnosis for thyroid nodules is fine needle aspiration (FNA); however, fine needle aspiration cytology (FNAC) alone is insufficient to detect cancer because of inadequate cytology (5-15%) and in cases of follicular neoplasm (15-25%) where only surgery is diagnostically conclusive. Therefore, other factors in addition to FNA should be considered to predict malignancy. This study is done to evaluate the association between elevated pre-operative thyroglobulin levels and histopathologically proven thyroid carcinoma.\n\nMetabolism of thyroglobulin occurs in the liver and via thyroid gland and recycling of the protein takes place. Circulating thyroglobulin features a half lifetime of 65 hours. Following thyroidectomy, it will take many weeks before thyroglobulin levels become undetectable. After thyroglobulin levels become undetectable (following thyroidectomy), levels are often serially monitored.\n\nA subsequent elevation of the thyroglobulin level is an indicator of recurrence of papillary or follicular thyroid carcinoma. Hence, thyroglobulin levels in the blood are mainly used as a tumor marker for certain kinds of thyroid cancer (particularly papillary or follicular thyroid cancer). Thyroglobulin is not produced by medullary or anaplastic carcinoma.\n\nTherefore, this study tries to evaluate the association between the preoperative thyroglobulin levels and thyroid carcinoma proven by post-operative histopathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Patients with thyroid nodules', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age between 15 to 70 years old\n2. patients with solitary thyroid nodules\n3. pateints who are fit for surgeries\n\nExclusion Criteria:\n\n* 1\\_patients who are unfit for surgeries\n\n 2\\_ age below 15 years and above 70 years old\n\n 3-patients with thyroid nodule receiving drugs that affect thyroglobulin level as iodine'}, 'identificationModule': {'nctId': 'NCT06157632', 'briefTitle': 'Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Preoperative Serum Thyroglobulin Level to Differentiate Between Different Thyroid Nodules', 'orgStudyIdInfo': {'id': 'Thyroglobulin level'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with thyoid nodules', 'description': 'Patients with thyroid nodules that will do thyroidectomy', 'interventionNames': ['Procedure: Thyriodectomy']}], 'interventions': [{'name': 'Thyriodectomy', 'type': 'PROCEDURE', 'description': 'Thyroidectomy', 'armGroupLabels': ['Patients with thyoid nodules']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ahmed Gamal, Master', 'role': 'CONTACT', 'email': 'Gamal8431@gmail.com', 'phone': '01062142009'}, {'name': 'Mohamed Hasan, Prof', 'role': 'CONTACT', 'email': 'mh.osman@yahoo.com', 'phone': '0 122 3971586'}], 'overallOfficials': [{'name': 'Mohamed Baker, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Mahmoud Thabet, Assistant.prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor at general surgery departement assiut university', 'investigatorFullName': 'Ahmed Gamal Hussein Hasan', 'investigatorAffiliation': 'Assiut University'}}}}