Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT06155305
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2023-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The primary tumor tissue and blood will be stored and used to identify potential biomarker for chemotherapy.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-11-24', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes.', 'timeFrame': '2023.12-2025.06', 'description': 'The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.'}], 'secondaryOutcomes': [{'measure': 'Comparison between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.', 'timeFrame': '2023.12-2025.06', 'description': 'The sensitivity and specificity would be checked between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Organoids', 'Breast Cancer', 'Neoadjuvant Chemotherapy']}, 'descriptionModule': {'briefSummary': "Breast cancer is the most common malignancy in women worldwide. Patients with breast cancer are often diagnosed at later stages and have a strong desire for breast conservation, necessitating neoadjuvant chemotherapy. Tumors of different molecular subtypes and individual variations among patients lead to significant differences in treatment efficacy. Precise assessment of patients' responses to treatment regimens is imperative in advancing prognosis of breast cancer. In this study, 58 patients diagnosed with breast cancer and scheduled for neoadjuvant therapy will be recruited. Patient-derived organoids from their tumor biopsies will be utilized to evaluate the sensitivity of chemotherapy regimen. These drugs primarily include Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, as well as targeted therapies such as Herceptin and Pertuzumab.", 'detailedDescription': '58 early-stage breast cancer patients scheduled to undergo neoadjuvant therapy will be recruited. Baseline information including medical history, ultrasound, Breast-Specific Gamma Imaging (BSGI), and magnetic resonance imaging (MRI) records, will be collected both before and after two cycles of chemotherapy. Tumor tissue from these patients will be obtained via biopsies guided by ultrasound. Patient-derived organoids (PDOs) will be established and cultured from the collected tumor tissue. Subsequently, these PDOs will be subjected to treatment with drugs from standard chemotherapeutic regimens for breast cancer. The growth of the organoids will be assessed post-treatment, and dose-response curves will be generated. For evaluating the clinical outcomes of the patients, the Residual Cancer Burden (RCB) system will be used to evaluate tumor histological responses in patients. The consistency between treatment responses observed in the PDO models and the clinical outcomes of patients will be evaluated through correlation analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer (AJCC stages I to IIIA) who need to receive neoadjuvant therapy.', 'genderDescription': 'Male breast cancer is a rare disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent form and willingness to participate in the clinical study.\n2. Female patients aged between 18 and 70 years old.\n3. Confirmed early-stage breast cancer eligible for surgery (AJCC stages I to IIIA), with a tumor diameter of ≥ 2cm detected by MRI and without distant metastasis (M0).\n\n The largest lesion among multiple lesions has a diameter of ≥ 2cm.\n4. ECOG performance status score of 0-1.\n5. No significant abnormalities in liver and kidney function (BIL \\<1.5-fold upper limit of normal (ULN)；ALT\\<2.5×ULN; AST\\<2.5×ULN；Crea≤1×ULN).\n\nExclusion Criteria:\n\n1. Received prior treatments.\n2. Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III).\n3. Bilateral breast cancer.\n4. Multiple breast cancers distributed in different quadrants.\n5. Patients not suitable for neoadjuvant chemotherapy.'}, 'identificationModule': {'nctId': 'NCT06155305', 'acronym': 'ONAC', 'briefTitle': 'Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Consistency of Organoids Based Drug Sensitivity and Efficacy of Neoadjuvant Chemotherapy in Breast Cancer', 'orgStudyIdInfo': {'id': '2023-0840'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients', 'description': 'Patients diagnosed with breast cancer undergo biopsy before initiating neoadjuvant therapy.', 'interventionNames': ['Procedure: Biopsy']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Before initiating neoadjuvant therapy, patients diagnosed with breast cancer undergo a tumor biopsy. The tissue obtained from the biopsy is utilized to establish organoids and conduct drug testing.', 'armGroupLabels': ['Breast cancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhigang chen', 'role': 'CONTACT', 'email': 'chenzg@zju.edu.cn', 'phone': '+8657189713716'}], 'facility': '2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'ZHIGANG CHEN', 'role': 'CONTACT', 'email': 'chenzg@zju.edu.cn', 'phone': '+8657189713716'}, {'name': 'Jian Huang', 'role': 'CONTACT', 'email': 'drhuangjian@zju.edu.cn', 'phone': '+8657189713716'}], 'overallOfficials': [{'name': 'Jian Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}, {'name': 'Zhigang Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}