Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 10:56 AM
Study NCT ID:
NCT04258735
Status:
UNKNOWN
Last Update Posted:
2020-02-06
First Post:
2019-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic Characteristics of Metastatic Breast Cancer Patients
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2019-07-23', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Genomic profiling of MBC patients', 'timeFrame': '60 months', 'description': 'Gemetic alteration frequency, the association between genetic alteration and survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Genomic analysis for metastatic breast cancer(MBC) patients\n\n* Participant (Inclusion criteria)\n\n 1. Patients who diagnosed metastatic/stage IV breast cancer\n 2. Patients who were not received treatment for metastatic breast cancer on palliative setting\n* Process\n\n (1) Tissue/ Blood sample\n* At diagnosis, MBC tissue / blood sample (20cc) will be obtained.\n* At disease progression after 1st line treatment for MBC, blood sample (20cc) will be obtained (tissue; optional)\n\n (2) WES, RNASeq, ctDNA, Exosome\n* We will analyze genomic characteritics using WES, RNASeq, ctDNA, Exosome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who diagnosed ad metastatic breast cancer\n* Patients who were not received treatment on palliative setting\n\nExclusion Criteria:\n\n* Patients who did not agree this study\n* Patients who did not have any pathologic specimen at MBC diagnosis.'}, 'identificationModule': {'nctId': 'NCT04258735', 'briefTitle': 'Genetic Characteristics of Metastatic Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Genetic Characteristics of Metastatic Breast Cancer Patients', 'orgStudyIdInfo': {'id': '2019-05-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Metastatic breast cancer cohort', 'description': 'Metastatic breast cancer with genetic tests including WES, RNASeq, ctDNA and exosome', 'interventionNames': ['Diagnostic Test: Genomic analysis']}], 'interventions': [{'name': 'Genomic analysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'WES, RNASeq, ctDNA, Exosome', 'armGroupLabels': ['Metastatic breast cancer cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Hyuck Im, MD, PhD', 'role': 'CONTACT', 'email': 'yh00.im@samsung.com', 'phone': '+82-2-3410-3445'}], 'facility': 'Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Young-Hyuck Im, MD,PhD', 'role': 'CONTACT', 'email': 'yh00.im@samsung.com', 'phone': '82-2-3410-3459'}, {'name': 'Ji-Yeon Kim, MD', 'role': 'CONTACT', 'email': 'jyeon25.kim@samsung.com', 'phone': '82-2-3410-3459'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Young-Hyuck Im', 'investigatorAffiliation': 'Samsung Medical Center'}}}}