Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-02-02 @ 6:37 PM
Study NCT ID:
NCT02947035
Status:
COMPLETED
Last Update Posted:
2023-07-14
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Testing to Direct Extent of Initial Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D016606', 'term': 'Thyroid Nodule'}], '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': 'D056741', 'term': 'Cyclin D'}], 'ancestors': [{'id': 'D016213', 'term': 'Cyclins'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018797', 'term': 'Cell Cycle Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2016-10-20', 'studyFirstSubmitQcDate': '2016-10-25', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who require completion thyroidectomy for aggressive histology features', 'timeFrame': '2 years', 'description': 'Histology characteristics of tumor will be assessed including type of cancer, extrathyroidal extension, lymph node metastasis, and margin status to assess if completion thyroidectomy is needed per the 2015 ATA guidelines'}], 'secondaryOutcomes': [{'measure': 'Number of patients who had central compartment neck dissection but no lymph node metastasis were identified', 'timeFrame': '2 years'}, {'measure': 'Number of patients with operative complications', 'timeFrame': '2 years', 'description': 'incidence of permanent nerve injury, hypocalcemia, readmission'}, {'measure': 'Recurrence', 'timeFrame': '>2 years'}, {'measure': 'QOL metric - FACT-G cumulative score preop, postop, and at followup', 'timeFrame': '2 years'}, {'measure': 'QOL metric - QOL-Thyroid cumulative score preop, postop, and at followup', 'timeFrame': '2 years'}, {'measure': 'QOL metric - SF36 cumulative score preop, postop, and at followup', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroid cancer', 'thyroid nodule', 'thyroidectomy', 'personalized medicine'], 'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'The research study consists of the participant agreeing to 1) the use of preoperative molecular testing (ThyroSeq) to guide extent of initial surgery and 2) the prospective collection of medical record data related to treatment of thyroid cancer.', 'detailedDescription': 'The aim of the proposed pilot study is to use a clinical algorithm that incorporates molecular, clinical and radiographic factors to inform surgical management. This study is the first to propose molecular-directed surgical management for this commonly diagnosed cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thyroid nodule is \\>1.5 cm\n* Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer\n\nExclusion Criteria:\n\n* Prior thyroid/parathyroid surgery\n* Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when \\<18 years old\n* Recurrent laryngeal nerve dysfunction\n* Diagnosis of concurrent primary hyperparathyroidism'}, 'identificationModule': {'nctId': 'NCT02947035', 'briefTitle': 'Molecular Testing to Direct Extent of Initial Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Molecular Testing to Direct Extent of Initial Thyroid Surgery', 'orgStudyIdInfo': {'id': 'STUDY19050280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Risk', 'description': 'Molecular testing and ultrasound features will be used to predict if thyroid cancer is low risk. Intervention will be to perform thyroid lobectomy.', 'interventionNames': ['Procedure: Thyroid lobectomy']}, {'type': 'EXPERIMENTAL', 'label': 'High Risk', 'description': 'Molecular testing and ultrasound features will be used to predict if thyroid cancer is high risk. Intervention will be to perform more aggressive surgery to include total thyroidectomy with CCND.', 'interventionNames': ['Procedure: Total thyroidectomy with CCND']}], 'interventions': [{'name': 'Thyroid lobectomy', 'type': 'PROCEDURE', 'description': 'Thyroid lobectomy is removal of only part of the thyroid', 'armGroupLabels': ['Low Risk']}, {'name': 'Total thyroidectomy with CCND', 'type': 'PROCEDURE', 'description': 'Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes', 'armGroupLabels': ['High Risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Linwah Yip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Linwah Yip', 'investigatorAffiliation': 'University of Pittsburgh'}}}}