Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-04-19 @ 5:12 PM
Study NCT ID:
NCT05526261
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom improvement', 'timeFrame': 'One year follow upp', 'description': 'Which sypmtoms become better after hemithyroidectomy'}], 'secondaryOutcomes': [{'measure': 'Comparision of questionnaries', 'timeFrame': '2024', 'description': 'The patients are going to fill in 4 different questionnaries in 3 different time intervalls. Before the operation, 1 month and 1 year efter the operation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'Nodules in the thyroid gland are common. Patients discover these lumps either because of their visible size increase or because of local discomforts such as difficulty swallowing, difficulty breathing or voice changes. The thyroid gland is in close connection with the esophagus, trachea and the vocal nerve. Thus, a lump in the thyroid gland can cause pressure symptoms from these organs. In the event of such complaints, patients are referred for investigation. If it turns out that the patient has a lump in the thyroid gland ("goiter"), further investigation is carried out with an ultrasound examination and sampling with a needle from the lump (puncture).\n\nAt present, most thyroid nodules are examined cytologically, ie the thyroid nodules are punctured with a thin needle and the cells that are obtained are analyzed by a cytologist. The material is graded according to Bethesda classification. Higher grading is associated with a higher risk that the tuber is malignant. Lower grading is associated with a lower probability that the tuber can be malignant. If these patients are operated on, it is usually with the hope that their local ailments improve.\n\nWe want to investigate which patients who have a lump in the thyroid gland and experience pressure problems experience an improvement after a thyroid operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patientens with compression symptoms in the neck', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a thyroid nodule who have local problems and where surgery (hemithyroidectomy) is planned\n* 18 years or older\n* Bethesda I-IV\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05526261', 'briefTitle': 'Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Benign Thyroid Nodules / Benign Goiter. What Subjective Problems Are Improved With an Operation and Can This be Predicted Preoperatively?', 'orgStudyIdInfo': {'id': '2020-00022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hemithyroidectoy', 'type': 'PROCEDURE', 'description': 'Hemithyroidectomy it is a surgical procedure where half of the thyroid gland is operated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '58729', 'city': 'Linköping', 'state': 'Östergötland County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ervin Beka', 'role': 'CONTACT', 'email': 'ervin.beka@regionostergotland.se', 'phone': '0738430968'}], 'facility': 'Linköpings University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'centralContacts': [{'name': 'Ervin Beka', 'role': 'CONTACT', 'email': 'ervin.beka@regionostergotland.se', 'phone': '0738430968'}], 'overallOfficials': [{'name': 'Oliver Gimm, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor Oliver Gimm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon MD', 'investigatorFullName': 'Ervin Beka', 'investigatorAffiliation': 'Linkoeping University'}}}}