Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
Study NCT ID:
NCT02363595
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2015-02-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genomic Predictors of Papillary Microcarcinoma Disease Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563277', 'term': 'Papillary Thyroid Microcarcinoma'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'estimate the disease progression rate', 'timeFrame': '4 years', 'description': 'Therefore, in order to ensure that we will have at least 459 patients with PTC being followed with active surveillance, we plan to enroll 500 total patients, of which 350 will have FNA diagnostic for PTC (of which 99% are expected to have PTC) and 150 patients will have FNA suspicious for PTC (of which 113 would be expected to have PTC). This sample size will enable us to estimate the 5 year disease progression rate requiring intervention to within ±4% at 95% confidence level (using binomial calculation under the assumption that the study is not stopped early and the progression rate is not higher than 10%).'}]}, 'conditionsModule': {'keywords': ['Genomic Predictors', '14-277'], 'conditions': ['Papillary Microcarcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic?\n\nTherefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All papillary thyroid cancer patients evaluated at MSKCC clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist.\n* Being followed with active surveillance at MSKCC\n* Biopsied index nodule less than or equal to 2 cm in maximum dimension\n* Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry.\n\nExclusion Criteria:\n\n* Biopsied index nodule greater than 2 cm in any dimension\n* Age less than 18 yrs old'}, 'identificationModule': {'nctId': 'NCT02363595', 'briefTitle': 'Genomic Predictors of Papillary Microcarcinoma Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Genomic Predictors of Papillary Microcarcinoma Disease Progression', 'orgStudyIdInfo': {'id': '14-277'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Papillary Microcarcinoma', 'description': 'This clinical trial protocol describes implementation of a prospective observation protocol to standardize data collection and obtain permission to collect samples of PMC tumors in a cohort of PMC patients being followed with active surveillance. This will allow PMC tumors to be accurately classified as either stable or progressive over time and used for comprehensive molecular profiling if surgical removal is required during follow-up'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert Tuttle, MD', 'role': 'CONTACT', 'phone': '646-888-2716'}, {'name': 'Michael Berger, PhD', 'role': 'CONTACT', 'phone': '646-888-3386'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Robert Tuttle, MD', 'role': 'CONTACT', 'phone': '646-888-2716'}, {'name': 'Michael Berger, PhD', 'role': 'CONTACT', 'phone': '646-888-3386'}], 'overallOfficials': [{'name': 'Robert Tuttle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ohio State University', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}