Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-27 @ 7:13 PM
Study NCT ID:
NCT03260192
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2017-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in 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': '1. plasma separated within 2 hours in EDTA tubes, stored in -80 celsius refrigerator;\n2. plasma in Streck tube, shipped within 3 days to the lab.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2017-08-14', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'death of breast cancer', 'timeFrame': 'Follow-up time is estimated to be up to 5 years. The duration is from the date of diagnosis to date of death of breast cancer or date of death of any cause, whichever come first.', 'description': 'The event is defined as death of breast cancer, which is a separate measure'}], 'secondaryOutcomes': [{'measure': 'tumor recurrence or distant metastasis', 'timeFrame': 'Follow-up time is estimated to be up to 5 years.The duration is from diagnosis to local recurrence or distant metastasis of breast cancer. Patients were followed up every six months in first three years, then followed up once a year.', 'description': 'The event is defined as breast cancer local recurrence or distant metastasis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['circulating tumor DNA'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy", 'detailedDescription': 'Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.In recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. An effective method to monitor the response to NAC is important.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patient receiving NAC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients undergoing NAC\n* Age: 18-70 yrs\n* Any menopausal status\n* Any hormal receptor status\n\nExclusion Criteria:\n\n* Metastasis discovered during NAC\n* Lost more than 2 blood samples during NAC and surgery'}, 'identificationModule': {'nctId': 'NCT03260192', 'briefTitle': 'Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer', 'orgStudyIdInfo': {'id': 'LQBC020'}}, 'contactsLocationsModule': {'locations': [{'city': 'Guandong', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shunying Li', 'role': 'CONTACT', 'email': 'lishunying@foxmail.com', 'phone': '+86-15915939702'}], 'facility': 'Sunyat-sen Memorial Hospital'}], 'centralContacts': [{'name': 'Shunying Li', 'role': 'CONTACT', 'email': 'lishunying@foxmail.com', 'phone': '+86-15915939702'}], 'overallOfficials': [{'name': 'qiang Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liu Qiang', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}