Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-30 @ 6:46 PM
Study NCT ID:
NCT01149161
Status:
UNKNOWN
Last Update Posted:
2016-04-21
First Post:
2010-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2022-02-07', 'unreleaseDate': '2022-02-07'}, {'releaseDate': '2022-02-08', 'unreleaseDate': '2022-02-13'}, {'resetDate': '2022-07-15', 'releaseDate': '2022-03-21'}, {'resetDate': '2023-07-12', 'releaseDate': '2022-08-22'}, {'resetDate': '2024-03-01', 'releaseDate': '2023-07-25'}], 'estimatedResultsFirstSubmitDate': '2022-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2010-06-02', 'studyFirstSubmitQcDate': '2010-06-22', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Is routine neck node dissection necessary in micro PTC?', 'timeFrame': 'Until 5 year follow-up. (Dec. 2016)', 'description': 'To see the necessity of routine neck node dissection in micro PTC, we will compare the recurrence rate and other complication (e.g. hoarseness and hypocalcemia) between group I(no dissection) and group III(routine dissection) after completion of study(after 5 year f/u).\n\nTo check the safety of this study, our result will be checked by korea institutional reveiw board every one year.'}], 'secondaryOutcomes': [{'measure': 'The efficacy of sentinel lymph node biopsy in micro PTC', 'timeFrame': 'Until 5 year follow-up. (Dec. 2016)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neck dissection', 'sentinel lymph node', 'Carcinoma', 'Papillary', 'thyroid', 'dissection'], 'conditions': ['Carcinoma']}, 'descriptionModule': {'briefSummary': 'Occult lymph node metastasis is common in micro papillary thyroid cancer. However, the role of lymph node dissection in the treatment of microPTC remains controversial. The investigators want to investigate the usefulness routine central dissection and sentinel lymph node biopsy in prognosis of micro PTC. This is a prospective randomized control study. The investigators started this study from May of 2009 and this study will be continued until Dec. 2011.', 'detailedDescription': 'The investigators will assign all patients to three groups; no dissection group (Group I), sentinel lymph node biopsy only group (Group II) and routine central neck dissection group (Group III). At first, to know the necessity of routine central neck node dissection for micro PTC,the investigators will compare the result of group I and group III. Additionally, the investigators can analyze the usefulness of sentinel lymph node biopsy for substitution of routine central neck node dissection for micro PTC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* papillary carcinoma of thyroid (less than 4cm)\n* no evidence of lymph node metastasis in preoperative work-up result\n* the patients who accept this study\n\nExclusion Criteria:\n\n* large thyroid cancer( \\> 4cm)\n* morbid\n* anticoagulation agent usage\n* endoscopic or robotic thyroid operation\n* evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan'}, 'identificationModule': {'nctId': 'NCT01149161', 'briefTitle': 'Extent of Central Lymph Node Dissection in Papillary Thyroid Microcarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Sentinel Lymph Node Biopsy in the Thyroid Carcinoma; Randomized, Prospective Study', 'orgStudyIdInfo': {'id': '2009-02-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'C group', 'description': 'Routine central neck dissection', 'interventionNames': ['Procedure: Routine central neck dissection']}, {'type': 'NO_INTERVENTION', 'label': 'N group', 'description': 'No central neck node dissection'}], 'interventions': [{'name': 'Routine central neck dissection', 'type': 'PROCEDURE', 'description': 'Level VI neck node dissection during thyroid operation', 'armGroupLabels': ['C group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jee Soo Kim, M.D., Ph.D.', 'role': 'CONTACT', 'phone': '82-2-3410-3479'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jee Soo Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'js0507.kim@samsung.com', 'phone': '82-2-3410-3479'}], 'overallOfficials': [{'name': 'Jee Soo Kim, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jee soo Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-02-07', 'type': 'RELEASE'}, {'date': '2022-02-07', 'type': 'UNRELEASE'}, {'date': '2022-02-08', 'type': 'RELEASE'}, {'date': '2022-02-13', 'type': 'UNRELEASE'}, {'date': '2022-03-21', 'type': 'RELEASE'}, {'date': '2022-07-15', 'type': 'RESET'}, {'date': '2022-08-22', 'type': 'RELEASE'}, {'date': '2023-07-12', 'type': 'RESET'}, {'date': '2023-07-25', 'type': 'RELEASE'}, {'date': '2024-03-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jee soo Kim, Professor, Samsung Medical Center'}}}}