Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 5:57 PM
Study NCT ID:
NCT04216732
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2019-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018276', 'term': 'Carcinoma, Medullary'}], 'ancestors': [{'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-11', 'size': 247945, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-02-28T10:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2030}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2019-11-14', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Natural history of medullary thyroid cancer (MTC)', 'timeFrame': 'Up to 4 years', 'description': 'Will describe the natural history of MTC using comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in existing multi-institutional patient registry.'}, {'measure': "Patients' experience with the different phases of MTC", 'timeFrame': 'Up to 4 years', 'description': "Will characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs)."}, {'measure': 'Association of selected biometric and patient-reported outcomes', 'timeFrame': 'Up to 4 years', 'description': 'Will evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Thyroid Gland Medullary Carcinoma', 'Stage III Thyroid Gland Medullary Carcinoma AJCC v8', 'Stage IV Thyroid Gland Medullary Carcinoma AJCC v8', 'Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8', 'Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8', 'Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'http://www.mdanderson.org'}]}, 'descriptionModule': {'briefSummary': 'This study utilizes a multi-institutional registry to describe the natural history of medullary thyroid cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) in understanding disease management. The goal of this study is to learn about how medullary thyroid cancer develops and progresses.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To describe the natural history of medullary thyroid cancer (MTC) using a comprehensive battery of demographic, clinical, pathologic, and genotypic variables collected in our existing multi-institutional patient registry.\n\nIa. To describe the demographic, clinical, pathologic, and genotypic variables associated with each phase of disease.\n\nIb. To identify those variables which are predictors of progression to the most advanced phases of disease that require small molecule therapy, including commercially approved and experimental agents.\n\nII. To characterize patients' experience with the different phases of MTC through a systematic evaluation of patient-reported outcomes (PROs).\n\nIIa. To describe clinical, psychosocial, economic, and physical well-being variables and the subsequent impact on quality of life associated with each phase of disease.\n\nIIb. To evaluate longitudinal changes in clinical, psychosocial, economic, and physical well-being variables between and within all phases of MTC, and the subsequent impact they have on quality of life.\n\nIII. To evaluate the association of selected biometric and patient-reported outcomes on adherence, change, and discontinuation of approved targeted therapies and drugs being tested within clinical trial.\n\nOUTLINE:\n\nAIM I \\& II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.\n\nAIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.\n\nThe questionnaire data gets paired with the collected medical record history that is maintained in the Registry."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with MTC including advanced phase MTC determined by clinical team', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aims 1 and 2: A diagnosis of MTC\n* Aims 1 and 2: A registrant in the Medullary Thyroid Cancer Registry (MTCR). Patients of all disease phases will be eligible for enrollment\n* Aim 3: A diagnosis of advanced phase (red or gray) MTC as determined by clinical team\n* Aim 3: A current registrant in the MTCR'}, 'identificationModule': {'nctId': 'NCT04216732', 'briefTitle': 'Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Utilization of the Natural History of Medullary Thyroid Carcinoma to Inform Advanced Disease Management', 'orgStudyIdInfo': {'id': '2019-0769'}, 'secondaryIdInfos': [{'id': 'NCI-2019-07526', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2019-0769', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational (questionnaire, blood pressure)', 'description': 'AIM I \\& II: Patients complete questionnaires over 10-40 minutes 2-4 times per year about health and how finances and quality of life effect experience with disease.\n\nAIM III: Patients complete a questionnaire over 2 minutes and undergo blood pressure measurements every day for up to 12 weeks.', 'interventionNames': ['Other: Blood Pressure Measurement', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Blood Pressure Measurement', 'type': 'OTHER', 'description': 'Undergo blood pressure measurement', 'armGroupLabels': ['Observational (questionnaire, blood pressure)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Observational (questionnaire, blood pressure)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Julie A. Sosa', 'role': 'CONTACT', 'phone': '415-476-1236'}, {'name': 'Julie A. Sosa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth G. Grubbs', 'role': 'CONTACT', 'email': 'eggrubbs@mdanderson.org', 'phone': '713-792-6940'}, {'name': 'Elizabeth G. Grubbs', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Elizabeth G Grubbs', 'role': 'CONTACT', 'email': 'eggrubbs@mdanderson.org', 'phone': '713-792-6940'}], 'overallOfficials': [{'name': 'Elizabeth G Grubbs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}