Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-26 @ 7:45 AM
Study NCT ID:
NCT03511859
Status:
UNKNOWN
Last Update Posted:
2018-04-30
First Post:
2018-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics
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': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-27', 'studyFirstSubmitDate': '2018-04-17', 'studyFirstSubmitQcDate': '2018-04-27', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects.', 'timeFrame': '3 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer. Circulating tumor cells. CTCs. Cell free DNA. cfDNA'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for cancer management throughout the course of the disease.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects need to sign the informed consent form and age is above 20.\n* Control group need to have mammogram /ultrasound results category1-3 and confirmed by PI.\n* Cancer group subjects with pathology report confirmed to be malignant have not yet done surgery or treatment will be enrolled to the malignant group for analysis\n\nExclusion Criteria:\n\n* Not willing to sign the informed consent form\n* Have been undergone general anesthesia or regional anesthesia in 1 month\n* Have been diagnosed with any type of cancer and been treated\n* Have been suffering from autoimmune disorder such as SLE and RA\n* Have been suffering from chronic infection such as IBD, pancreatitis, COPD or Interstitial pneumonia.\n* Have been suffering from acute infection or other infectious diseases in 3 moths such as TB, pneumonia, urinary tract infection, or cellular infection\n* Diagnosed with myelodysplastic syndrome or myeloproliferative diseases\n* Other condition which may affect the CTC results, when determined by PI can be confirmed by other tests are if necessary'}, 'identificationModule': {'nctId': 'NCT03511859', 'briefTitle': 'Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics', 'organization': {'class': 'INDUSTRY', 'fullName': 'CellMaxLife'}, 'officialTitle': 'Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics', 'orgStudyIdInfo': {'id': 'CMx-CTC-BC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control Group', 'description': 'Mammography/ultrasonography confirmed no findings.'}, {'label': 'Cancer Group', 'description': 'The biopsy result is breast cancer.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ming-Feng Hou', 'role': 'CONTACT'}], 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Joy Chang', 'role': 'CONTACT', 'email': 'joy@cellmaxlife.com', 'phone': '+886-2-26558455'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CellMaxLife', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}