Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 1:12 PM
Study NCT ID:
NCT03480659
Status:
TERMINATED
Last Update Posted:
2023-12-21
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA extracted from plasma and PBMC'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Experienced technical issues with plasma blood samples collected from patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-18', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of breast cancer', 'timeFrame': '6 months to 1 year', 'description': 'We will develop the linear model and a threshold value differentiating breast cancer from control based on the 100 patient training set. The model will be provided to the researchers:\n\nMethylation score=CG1\\*b1+CG2\\*b2+ CG3\\*b3 + e\n\nCG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and e equals the intercept.\n\nWe will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. We will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as breast cancer or not.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'A central challenge in the fight against breast cancer is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast cancer, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of breast cancer are urgently needed.\n\nThe purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in breast cancer patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of Breast cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form', 'genderDescription': 'Breast cancer females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmed breast cancer subtypes (DCIS and invasive)\n\nExclusion Criteria:\n\n* Pregnant women\n* Minors (subjects less than 18 years of age)\n* Prisoners\n* Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C\n* Patients having other than one cancer\n* Subjects unable to consent for themselves'}, 'identificationModule': {'nctId': 'NCT03480659', 'briefTitle': 'Detection of Breast Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC', 'organization': {'class': 'INDUSTRY', 'fullName': 'HKGepitherapeutics'}, 'officialTitle': 'Breast Cancer Screening Using DNA Methylation Changes in Circulated Tumor, PBMC and T-cells DNA.', 'orgStudyIdInfo': {'id': 'HKG-KZ-BrCa-101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer', 'description': 'Early stage luminal A and triple negative breast cancer \\[TNBC\\] (estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) and HER2-negative (HER2-)'}, {'label': 'Control', 'description': 'Age matched control females'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Almaty', 'country': 'Kazakhstan', 'facility': 'Kazakh Institute of Oncology and Radiology', 'geoPoint': {'lat': 43.25249, 'lon': 76.9115}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HKGepitherapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kazakh Research Institute of Oncology & Radiology', 'class': 'OTHER'}, {'name': 'Montreal EpiTerapia Inc.', 'class': 'INDUSTRY'}, {'name': 'Canada-Kazakhstan EpiTerapia Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}