Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-01-25 @ 12:29 AM
Study NCT ID:
NCT05305092
Status:
RECRUITING
Last Update Posted:
2022-07-13
First Post:
2022-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Brain Cognitive Impairment 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, gut microbiota'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-03-06', 'studyFirstSubmitQcDate': '2022-03-22', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of gray matter volume of whole brain', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Gray matter volume will be measured with magnetic resonance imaging (high resolution T1-weighted image)'}, {'measure': 'Change of white matter integrity of whole brain.', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Fractional anisotropy, axial diffusivity and radial diffusivity will be measured with magnetic resonance imaging (diffusion tensor imaging)'}, {'measure': 'Change of metabolism of glucose in the brain', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Accumulation of 18F-fluorodeoxyglucose(18F-FDG) will be analyzed by time-related Positron emission tomography'}, {'measure': 'Change of functional connectivity of whole brain', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Functional connectivity will be measured with magnetic resonance imaging based on blood oxygen level dependence'}, {'measure': 'Change of verbal learning and memory', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Verbal learning and memory scores will be assessed with Hopkins Verbal Learning Test-Revised.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.'}, {'measure': 'Change of information processing speed', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Information processing speed scores will be assessed with Wechsler Adult Intelligence Scale(WAIS-III) Digit Symbol Coding score.The minimum value is 0, and the maximum value is 90. The higher scores mean a better outcome.'}, {'measure': 'Change of executive function', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Executive function scores will be assessed with Stroop color-word test.The minimum value is 0, and the maximum value is 50. The higher scores mean a better outcome.'}, {'measure': 'Change of attention, verbal short term and working memory', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Attention, verbal short term and working memory scores will be assessed with Digit span.The minimum value is 0, and the maximum value is 12. The higher scores mean a better outcome.'}, {'measure': 'Change of life quality.', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Quality of life scores will be assessed with Quality-of-Life Questionnaire C30. The minimum value is 30, and the maximum value is 126. The higher scores mean a worse outcome.'}, {'measure': 'Change of anxiety', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Anxiety scores will be assessed with Self-Rating Anxiety Scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.'}, {'measure': 'Change of depression', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Depression scores will be assessed with Self-rating depression scale.The minimum value is 20, and the maximum value is 80. The higher scores mean a worse outcome.'}, {'measure': 'Change of fatigue', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Fatigue scores will be assessed with Fatigue Severity Scale. The minimum value is 9, and the maximum value is 63. The higher scores mean a worse outcome.'}, {'measure': 'Change of sleep', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'Sleep scores will be assessed with Pittsburgh sleep quality index.The minimum value is 9, and the maximum value is 36. The higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change of the concentration of serum biomarkers.', 'timeFrame': 'Baseline, 6,18,30 months later', 'description': 'The concentration of GFAP with pg/mL, S-100B with pg/mL，IL-6 with pg/mL, IL-8 with pg/mL, IL-10 with pg/mL, IL-1β with pg/mL, TNF-α with pg/mL, UCH-L1 with pg/mL, NSE with pg/mL, T-Tau with pg/mL, P-Tau with pg/mL, NFL with pg/mL, BDNF with pg/mL, and VEGF with pg/mL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CRCI', 'psycho-behavioral technology', 'Integrated PET/MRI technology', 'Biomarkers'], 'conditions': ['Breast Cancer', 'Chemo-brain', 'Endocrine Therapy']}, 'descriptionModule': {'briefSummary': 'To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.', 'detailedDescription': 'Breast cancer is the most common type of cancer in women worldwide, and cancer-related cognitive impairment (CRCI) has become one of the most concerning clinical problems in breast cancer treatment. This project intends to use the combination of advanced PET/MRI technology and psycho-behavioral methods to observe the cognitive impairment and the changes in brain structure, function and glucose metabolism caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients, then looking for possible predictors, through early identification of patients at risk of cognitive decline after chemotherapy or endocrine therapy, to provide a scientific basis for the rational selection of breast cancer treatment plans in the future.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Premenopausal patients with stage I-II breast cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary stage I-II breast cancer.\n* Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).\n* No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).\n* Eastern Cooperative Oncology Group score of 0-1 points.\n* Can understand and complete various scales.\n* Right handedness.\n* Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.\n* Sign the informed consent and voluntarily participate in this clinical observation.\n\nExclusion Criteria:\n\n* Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.\n* Current or former epilepsy, dementia, or learning disabilities.\n* Past psychiatric history.\n* Past history of malignancy.\n* MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.'}, 'identificationModule': {'nctId': 'NCT05305092', 'briefTitle': 'Assessment of Brain Cognitive Impairment in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy', 'orgStudyIdInfo': {'id': '82071993'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'chemotherapy', 'description': 'Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery', 'interventionNames': ['Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample']}, {'label': 'Endocrine therapy', 'description': 'Premenopausal breast cancer patients receiving endocrine therapy alone after surgery', 'interventionNames': ['Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample']}, {'label': 'Healthy control', 'description': 'Healthy non-cancer controls', 'interventionNames': ['Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample']}], 'interventions': [{'name': 'PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample', 'type': 'DEVICE', 'description': 'Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.', 'armGroupLabels': ['Endocrine therapy', 'Healthy control', 'chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Menghui Yuan, PHD', 'role': 'CONTACT', 'email': 'yuanmenghui@163.com', 'phone': '0086-13519196610'}, {'name': 'Lijun Bai, PHD', 'role': 'CONTACT', 'email': 'bailijun@xjtu.edu.cn', 'phone': '0086-15129034948'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Menghui Yuan, phd', 'role': 'CONTACT', 'email': 'yuanmenghui@163.com', 'phone': '0086-13519196610'}, {'name': 'Lijun Bai, phd', 'role': 'CONTACT', 'email': 'bailijun@xjtu.edu.cn', 'phone': '0086-15129034948'}], 'overallOfficials': [{'name': 'Menghui Yuan, phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tang-Du Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Xi'an Jiaotong University", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}