Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 12:31 PM
Study NCT ID:
NCT01840332
Status:
COMPLETED
Last Update Posted:
2014-03-14
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-13', 'studyFirstSubmitDate': '2013-04-22', 'studyFirstSubmitQcDate': '2013-04-22', 'lastUpdatePostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change in biochemical parameters during the study', 'timeFrame': '4-6 weeks', 'description': 'Change in parameters related to hypothyroidism (thyroid hormones, creatinine kinase, cholesterol,ultra sensitive CRP, creatinine).'}], 'primaryOutcomes': [{'measure': 'TSH level at the end of study', 'timeFrame': '4-6 weeks', 'description': 'The percentage of patients obtaining TSH level at least 30 imU/L at the end of study period.\n\nBlood tests will be obtained after 4 weeks. If TSH \\> 30 the patient has completed the study. If TSH \\< 30 patient will continue for 1 week and blood tests will be obtained after week 5. If TSH \\> 30 the patient has completed the study. If TSH \\< 30 patient will be monitored during 1 week and blood tests will be obtained after 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'change in Billewitz index during the study', 'timeFrame': '4-6 weeks', 'description': 'Billewitz index measures the severity of hypothyroidism symptoms. Billewitz index will be recorded after 4 weeks and after 5 and 6 weeks if patient continues after 4 or 5 weeks (see primary endpoint for details).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thyroid cancer'], 'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.', 'detailedDescription': 'The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs.\n\nCurrent pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Differentiated thyroid cancer\n* treated by thyroidectomy and at least 1 ablation with 131-I \\> 5 months ago\n* TSH \\< 4 imU/L\n\nExclusion Criteria:\n\n* Pregnancy\n* Known metastasis'}, 'identificationModule': {'nctId': 'NCT01840332', 'briefTitle': 'Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Tartu'}, 'officialTitle': 'Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer', 'orgStudyIdInfo': {'id': '1.0 /29.08.2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-thyroxin', 'description': 'this is one arm study', 'interventionNames': ['Drug: L-thyroxin']}], 'interventions': [{'name': 'L-thyroxin', 'type': 'DRUG', 'description': 'Low dose of L-thyroxin (50 microg/day) will be used during 4 weeks. If TSH is \\< 30 after 4 weeks the study continues up to 6 weeks.', 'armGroupLabels': ['L-thyroxin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10138', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'East Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Vallo Volke, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tartu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Tartu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Vallo Volke', 'investigatorAffiliation': 'University of Tartu'}}}}