Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-11 @ 2:50 PM
Study NCT ID:
NCT03973034
Status:
UNKNOWN
Last Update Posted:
2019-06-04
First Post:
2019-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of ctDNA in Early Screening of Breast Cancer
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': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-02', 'studyFirstSubmitDate': '2019-06-02', 'studyFirstSubmitQcDate': '2019-06-02', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ctDNA test model for early screening of breast cancer', 'timeFrame': '2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ctDNA', 'early screening', 'Copy Number Variants (CNV)', 'Low Depth Whole Genome Sequencing (LDWGS)'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Three groups: normal people, benign breast disease patients and breast cancer patients in early stage.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.\n* Age of at least 18 and at most 70 years.\n* Normal people who works as the volunteers.\n* Benign breast disease patients should be diagnosed with confirmed pathology after surgery.\n* Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.\n* Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.\n\nExclusion Criteria:\n\n* Known hypersensitivity reaction to the investigational compounds or incorporated substances.\n* Local recurrence and/or metastasis of breast cancer.\n* Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.\n* Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).\n* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.\n* Concurrent treatment with other experimental drugs or any other anti-cancer therapy.\n* Males.'}, 'identificationModule': {'nctId': 'NCT03973034', 'briefTitle': 'Clinical Application of ctDNA in Early Screening of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Clinical Application of ctDNA in Early Screening of Breast Cancer', 'orgStudyIdInfo': {'id': 'PUMCH-BREAST-ctDNA screening'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal people', 'interventionNames': ['Diagnostic Test: Low depth whole genome sequencing']}, {'label': 'Benign breast disease patients', 'interventionNames': ['Diagnostic Test: Low depth whole genome sequencing']}, {'label': 'Breast cancer patients in early stage', 'interventionNames': ['Diagnostic Test: Low depth whole genome sequencing']}], 'interventions': [{'name': 'Low depth whole genome sequencing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Low depth whole genome sequencing of the peripheral blood samples from different groups.', 'armGroupLabels': ['Benign breast disease patients', 'Breast cancer patients in early stage', 'Normal people']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yidong Zhou, Doctor', 'role': 'CONTACT', 'email': 'zhouyd@pumch.cn', 'phone': '86-10-69155200'}, {'name': 'Ru Yao, Doctor', 'role': 'CONTACT', 'email': 'yaoru@pumch.cn', 'phone': '86-10-69152001'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}