Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT03935802
Status:
COMPLETED
Last Update Posted:
2019-05-02
First Post:
2019-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011827', 'term': 'Radiation'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-01', 'studyFirstSubmitDate': '2019-04-24', 'studyFirstSubmitQcDate': '2019-05-01', 'lastUpdatePostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'up to 10 years', 'description': 'from the start of Radiotherapy until death / last seen during follow up'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': 'up to 10 years', 'description': 'from the start of Radiotherapy until relapse or metastasis / last seen during follow up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiotherapy', 'CETC', 'CTC', 'breast cancer'], 'conditions': ['Breast Cancer Female']}, 'referencesModule': {'references': [{'pmid': '36661670', 'type': 'DERIVED', 'citation': 'Maurer M, Schott D, Pizon M, Drozdz S, Wendt T, Wittig A, Pachmann K. Increased Circulating Epithelial Tumor Cells (CETC/CTC) over the Course of Adjuvant Radiotherapy Is a Predictor of Less Favorable Outcome in Patients with Early-Stage Breast Cancer. Curr Oncol. 2022 Dec 24;30(1):261-273. doi: 10.3390/curroncol30010021.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.', 'detailedDescription': "In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary non-metastatic breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed invasive breast carcinoma\n* age \\>= 18 years\n* exclusive treatment at the Jena University Hospital\n* complete curative-intended adjuvant or definite radiotherapy\n* at least 2 blood collections (before the start of therapy, after the end of the RT)\n\nExclusion Criteria:\n\n* presence of metastases\n* recurrence\n* DCIS, inflammatory breast cancer\n* second malignancy \\<10 years before diagnosis of breast cancer\n* radiotherapeutic pretreatment'}, 'identificationModule': {'nctId': 'NCT03935802', 'briefTitle': 'Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy', 'orgStudyIdInfo': {'id': 'CETC 001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'primary non-metastatic breast cancer', 'description': 'primary non-metastatic breast cancer', 'interventionNames': ['Radiation: radiation']}], 'interventions': [{'name': 'radiation', 'type': 'RADIATION', 'armGroupLabels': ['primary non-metastatic breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Department of Radiooncology, Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Matthias Mäurer', 'investigatorFullName': 'Matthias Mäurer', 'investigatorAffiliation': 'University of Jena'}}}}