Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-06 @ 2:28 AM
Study NCT ID:
NCT01511393
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-06-13
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6750}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual incidence of MTC in the US to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.', 'timeFrame': 'Up to 15 years'}], 'secondaryOutcomes': [{'measure': 'Family history of cancer (including history of MEN2A or MEN 2B, history of FMTC, history of RET proto-oncogene mutations), Patient demographic characteristics, Patient prior history of thyroid diseases', 'timeFrame': 'Up to 15 years'}, {'measure': 'Dose and Duration of use of all previous diabetes medication exposures (including long acting and short acting GLP-1 receptor agonists, DPP4 inhibitors, and insulin)', 'timeFrame': 'Up to 15 years'}, {'measure': 'Dose and Duration of use of all previous weight management drugs (including long acting GLP-1 receptor agonists).', 'timeFrame': 'Up to 15 years'}, {'measure': 'Lifestyle factors such as smoking and alcohol use', 'timeFrame': 'Up to 15 years'}, {'measure': 'Environmental exposures (occupational history, radioiodine exposure, nuclear fallout)', 'timeFrame': 'Up to 15 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GLP1', 'Glucagon like peptide', 'liraglutide', 'exenatide extended release', 'dulaglutide', 'semaglutide', 'semaglutide tablets'], 'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2', 'Medullary Thyroid Carcinoma', 'Weight Management']}, 'referencesModule': {'references': [{'pmid': '33179845', 'type': 'DERIVED', 'citation': 'Major-Pedersen A, McCullen MK, Sabol ME, Adetunji O, Massaro J, Neugut AI, Sosa JA, Hollenberg AN. A joint industry-sponsored data monitoring committee model for observational, retrospective drug safety studies in the real-world setting. Pharmacoepidemiol Drug Saf. 2021 Jan;30(1):9-16. doi: 10.1002/pds.5172. Epub 2020 Nov 24.'}], 'seeAlsoLinks': [{'url': 'http://astrazenecagrouptrials.pharmacm.com/', 'label': 'AstraZeneca Pharmaceuticals LP'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new adult cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.', 'detailedDescription': 'This active surveillance program will monitor for any signal indicating a possible association between treatment with long-acting GLP-1 RAs and the development of MTC in the United States population. Given the very low incidence of MTC in the general population, the expected rate of exposure to long-acting GLP-1 RAs, the anticipated long latency of the potential outcome under study and the limited data on underlying risk factors for development of MTC other than RET proto-oncogene mutations, an active surveillance program is the most efficient means of identifying a possible association between MTC and products in the long-acting GLP-1 RAs class. Given the uncertainty of the association of MTC in humans treated with these drugs, a study duration of at least fifteen years from the time of market introduction of the first long-acting GLP-1 RA was thought to provide evidence of an association, if one exists. If such an association is identified, a case-control study will be initiated to quantify the association.\n\nThe MTC registry is a Food and Drug Administration (FDA) post-marketing requirement for long-acting GLP-1 RA products. Because of the rarity of MTC and in order to minimize inconvenience to patients, physicians, and state cancer registries, FDA encouraged sponsors of long-acting GLP-1 RAs to work collaboratively to conduct this registry. Consequently, the MTC Registry Consortium has been formed for this purpose.\n\nThe MTC Registry Consortium refers to the Sponsors with approved long-acting GLP-1 RAs who have a contractual agreement to participate in the MTC Registry.\n\nThis active surveillance program for cases of MTC will be conducted with assistance from the North American Association of Central Cancer Registries (NAACCR). NAACCR is a collaborative umbrella organization for cancer registries, government agencies, professional organizations, and private groups in North America interested in improving the quality and use of cancer registry data. All of the central cancer registries in the U.S. and Canada are members of NAACCR, including those that participate in SEER.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with medullary thyroid carcinoma invited by either written invitation from the participating cancer registry or the diagnosing physician to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries\n* At least 18 years or older.\n\nThere are no other inclusion or exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT01511393', 'briefTitle': 'An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry', 'orgStudyIdInfo': {'id': 'NN2211-3965'}, 'secondaryIdInfos': [{'id': 'U1111-1125-4362', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Questionnaire', 'description': 'None. Non-interventional study.', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'None. Non-interventional study.', 'armGroupLabels': ['Questionnaire']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26505-8065', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'United BioSource, LLC', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Annette Stemhagen, DrPH, FISPE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'United BioSource, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Currently this is undecided for this 15 year registry. The Data Monitoring Committee is a group of external interdisciplinary consultants who oversee the registry data to review if there are any signals or safety concerns with patients who have taken any of the long-acting GLP-1 RAs and were diagnosed with medullary thyroid carcinoma.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'United BioSource, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}