Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
Study NCT ID:
NCT04353557
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2020-04-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ctDNA Monitoring in Early 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'tumor and plasma specimens'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive ctDNA detection at first post-operative timepoint', 'timeFrame': '1 month post-surgery', 'description': 'The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint'}], 'secondaryOutcomes': [{'measure': 'Positive ctDNA detection at post-operative timepoints', 'timeFrame': '6/12/18/24/30 months', 'description': 'The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints'}, {'measure': 'Association between ctDNA detection and time to recurrence', 'timeFrame': '1 month post-surgery', 'description': 'Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison.'}, {'measure': 'Association between ctDNA detection and time to recurrence', 'timeFrame': '6/12/18/24/30 months', 'description': 'Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ctDNA'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stage I-III breast cancer who planed to receive curative-intent treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old\n2. Histologically proven primary breast cancer with clinical stage I-III\n3. Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated).\n4. Expected to achieve R0 resection.\n5. Estimated lifetime is more than 3 months.\n6. Signed Informed Consent Form\n7. Consent to provide research blood samples.\n\nExclusion Criteria:\n\n1. Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5.\n2. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5.\n3. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ.\n4. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT04353557', 'briefTitle': 'ctDNA Monitoring in Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Geneplus-Beijing Co. Ltd.'}, 'officialTitle': 'Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer', 'orgStudyIdInfo': {'id': 'Geneplus2020BC01'}}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Xu, M.D.', 'role': 'CONTACT', 'email': 'xy931@163.com', 'phone': '(+86)159 2310 0038'}], 'facility': 'Army Medical Center of PLA, China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yan Xu, M.D.', 'role': 'CONTACT', 'email': 'xy931@163.com', 'phone': '(+86)159 2310 0038'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Geneplus-Beijing Co. Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Army Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}