Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-01-08 @ 6:54 PM
Study NCT ID:
NCT02404818
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac Abnormalities As Measured By Cardiac MRI', 'timeFrame': 'Day 1'}, {'measure': 'Cardiac Abnormalities As Measured By Echocardiogram', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation', 'Cardiac', "Hodgkin's lymphoma"], 'conditions': ["Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.\n* Patient must be ≥ 18 years at time of consent.\n\nExclusion Criteria:\n\n* Pregnant women at time of Cardiac MRI\n* Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices)\n* Glomerular filtration rate (GFR) \\< 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).'}, 'identificationModule': {'nctId': 'NCT02404818', 'briefTitle': 'Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation', 'orgStudyIdInfo': {'id': 'UFPTI-1431-HL02'}, 'secondaryIdInfos': [{'id': 'IRB201703302', 'type': 'OTHER', 'domain': 'UF IRB-03'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Survivors of Hodgkin's lymphoma", 'description': 'Cardiac Magnetic Resonance Imaging and Echocardiogram', 'interventionNames': ['Procedure: Cardiac Magnetic Resonance Imaging', 'Procedure: Echocardiogram']}], 'interventions': [{'name': 'Cardiac Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'description': 'A cardiac MRI will be performed.', 'armGroupLabels': ["Survivors of Hodgkin's lymphoma"]}, {'name': 'Echocardiogram', 'type': 'PROCEDURE', 'description': 'An echocardiogram will be performed for the following information: M-mode, two-dimensional, Doppler blood flow measurements, and longitudinal strain and strain rate imaging', 'armGroupLabels': ["Survivors of Hodgkin's lymphoma"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '32206', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Proton Therapy Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Bradford S Hoppe, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida Health Proton Therapy Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}