Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-05 @ 5:42 AM
Study NCT ID:
NCT02364960
Status:
TERMINATED
Last Update Posted:
2018-08-22
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Study site will join the TARGIT-US trial in lieu of this trial', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-02-10', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-breast local failure and patterns of in-breast failure', 'timeFrame': '6 months after IORT through year 10', 'description': "In-breast local failure is defined as recurrence of cancer in the ipsilateral (same side) breast. Following IORT, patients will be monitored every 6 months for 3 years, and then annually in years 4 and 5 to determine if cancer has returned. In years 6 through 10 medical records will be reviewed to obtain information on participants' breast cancer status."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Early Stage Breast Cancer', 'Neoplasm of the Breast', 'Breast Tumor']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,', 'detailedDescription': 'A registry trial has been designed and modeled after the original successful TARGIT protocol, to continue the use of IORT for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Patients selected for breast conserving surgery, who are considered to have a low risk of local recurrence, are eligible for this registry trial once their informed consent is obtained. This single arm cohort study allows entry of patients who have been diagnosed with early stage breast cancer and whose clinical stage is suitable for treating conservatively (small tumor and no gross nodal involvement). Tumors should not be more than 3.5 cm in size.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer that is suitable for breast conserving surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 45 or greater\n* Diagnosed with operable invasive breast cancer, T1 and T2 (\\< 3.5 cm), N0, M0, confirmed by cytological or histological examination\n* Suited for breast conserving surgery\n* Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment\n\nExclusion Criteria:\n\n* age 44 or less\n* Axillary lymph node positive breast cancer\n* Invasive lobular cancer\n* Tumor size \\> 3.5 cm\n* Extensive Intraductal Component (EIC= \\> 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen\n* Multicentric cancer in the same breast not amenable to excision with a single lumpectomy\n* Inability to assess pathologic margin status\n* Synchronous bilateral breast cancer at the time of diagnosis.\n* Ipsilateral breast had a previous cancer and/or prior in-field radiation.\n* Patients known to have BRCA1/2 gene mutations\n* Neoadjuvant treatment (hormones or chemotherapy)'}, 'identificationModule': {'nctId': 'NCT02364960', 'acronym': 'TARGIT', 'briefTitle': 'Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)', 'orgStudyIdInfo': {'id': '14-047'}}, 'contactsLocationsModule': {'locations': [{'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mary Jo Cropper Family Center for Breast Care', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Ching Ho, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mary Jo Cropper Family Center for Breast Care'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'TriHealth Hatton Research Institute', 'class': 'OTHER'}, {'name': 'Bethesda North Hospital Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director, Mary Jo Cropper Family Center for Breast Care', 'investigatorFullName': 'Angela N Fellner PhD CCRP', 'investigatorAffiliation': 'TriHealth Inc.'}}}}