Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-01-22 @ 10:01 AM
Study NCT ID:
NCT00001160
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
1999-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies on Tumors of the Thyroid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536913', 'term': 'Thyroid cancer, Hurthle cell'}, {'id': 'D018263', 'term': 'Adenocarcinoma, Follicular'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D000077273', 'term': 'Thyroid Cancer, Papillary'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D000231', 'term': 'Adenocarcinoma, Papillary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C513399', 'term': 'gallium Ga 68 dotatate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '1977-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09-25', 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '1999-11-03', 'studyFirstSubmitQcDate': '1999-11-03', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-11-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of thyroid cancer', 'timeFrame': 'As clinically indicated', 'description': 'Blood draws, CT and other scans, physical exams, surgery (if applicable), thyroid biopsy (if applicable).'}, {'measure': 'Evaluation of thyroid disorders', 'timeFrame': 'As clinically indicated', 'description': 'blood draws, CT and other scans, physical exam.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid Fine Needle Biopsy', 'Radioiodine', 'Dosimetry', 'Natural History'], 'conditions': ['Hurthle Cell Thyroid Cancer', 'Tall Cell Variant Thyroid Cancer', 'Follicular Thyroid Cancer', 'Thyroid Cancer', 'Papillary Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '30032182', 'type': 'BACKGROUND', 'citation': 'Klubo-Gwiezdzinska J, Wartofsky L. The Role of Molecular Diagnostics in the Management of Indeterminate Thyroid Nodules. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3507-3510. doi: 10.1210/jc.2018-01081.'}, {'pmid': '31620364', 'type': 'BACKGROUND', 'citation': 'Thakur S, Tobey A, Daley B, Auh S, Walter M, Patel D, Nilubol N, Kebebew E, Patel A, Jensen K, Vasko V, Klubo-Gwiezdzinska J. Limited Utility of Circulating Cell-Free DNA Integrity as a Diagnostic Tool for Differentiating Between Malignant and Benign Thyroid Nodules With Indeterminate Cytology (Bethesda Category III). Front Oncol. 2019 Sep 18;9:905. doi: 10.3389/fonc.2019.00905. eCollection 2019.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_1977-DK-0096.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer.\n\nThe main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.', 'detailedDescription': 'The purpose of this study is to gain knowledge and experience in the diagnosis and therapy of thyroid cancer using established best standard of care and new techniques and approaches as they are developed. Study subjects will include adults and children with thyroid nodules requiring diagnostic imaging and fine needle aspiration biopsy, surgery, radioiodine scanning or therapy, appropriate follow up, consisting of tumor markers monitoring and anatomical and functional imaging. The limitations and significance of serum thyroglobulin (Tg) measurement for diagnosing tumor recurrence will be assessed. The study will permit a continued evaluation of the risk/benefit ratio of already established methods of administering radioiodine therapy, including the impact of pre-treatment dosimetric calculations, individualizing treatment with radioiodine. Under this protocol, samples of benign nodules and cancer tissue specimens for research studies will be collected. Data and samples collected during routine clinical care will be used to address research questions utilizing a number of approaches including microscopy, immunohistochemistry, proteomics and molecular analysis. All research studies will relate to the diagnosis, natural history and therapy of thyroid tumors, regulation of thyroid function, and the effects of thyroid function on the body. Blood and urine specimens will be collected for research studies in both the hypothyroid and euthyroid state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Only those with thyroid nodules and/or thyroid cancer will be allowed to enroll.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, adults or children \\>= 6 months+.\n2. Patients with known or suspected thyroid nodules and/or thyroid cancer.\n3. At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed.'}, 'identificationModule': {'nctId': 'NCT00001160', 'briefTitle': 'Studies on Tumors of the Thyroid', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Studies on Thyroid Nodules and Thyroid Cancer', 'orgStudyIdInfo': {'id': '770096'}, 'secondaryIdInfos': [{'id': '77-DK-0096'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'thyroid cancer', 'description': 'Patients with thyroid cancer', 'interventionNames': ['Drug: 68-Gallium Dotatate']}, {'label': 'thyroid nodules', 'description': 'Patients with thyroid nodules', 'interventionNames': ['Drug: 68-Gallium Dotatate']}], 'interventions': [{'name': '68-Gallium Dotatate', 'type': 'DRUG', 'description': 'For evaluation risk/benefit evaluation', 'armGroupLabels': ['thyroid cancer', 'thyroid nodules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Padmasree Veeraraghavan, R.N.', 'role': 'CONTACT', 'email': 'padmasree.veeraraghavan@nih.gov', 'phone': '(301) 451-7710'}, {'name': 'Joanna Klubo-Gwiezdzinska, M.D.', 'role': 'CONTACT', 'email': 'joanna.klubo-gwiezdzinska@nih.gov', 'phone': '(301) 496-5052'}], 'overallOfficials': [{'name': 'Joanna Klubo-Gwiezdzinska, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Subject level data will be shared upon request after appropriate collaboration agreements are in place.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}