Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-04-25 @ 1:06 PM
Study NCT ID:
NCT03137095
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, plasma, peripheral blood mononuclear cells (PBMC)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Research Brain MRI', 'timeFrame': 'After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment', 'description': 'MRI brain imaging to obtain structural and connectivity data via fMRI (brain function), T1MRI (brain structure) and DTI (white matter related microstructure in brain) to determine if there are changes within the brain related to cognitive performance, symptoms, immune and other biologic factors'}], 'primaryOutcomes': [{'measure': 'Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers', 'timeFrame': 'During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months', 'description': 'Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer Related Cognitive Difficulties', 'Breast Cancer Female']}, 'descriptionModule': {'briefSummary': 'Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria, Breast Cancer Patient Participants:\n\n* Females with a diagnosis of invasive non-metastatic breast cancer (stage I-IIIC)\n* Scheduled to begin a course of chemotherapy with Adriamycin and Cytoxan\n* Chemotherapy naïve\n* Able to speak and read English\n* 21 years or older\n* Give written informed consent\n\nExclusion Criteria, Breast Cancer Patient Participants:\n\n* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness\n* Must not be diagnosed with a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n* Must not have any Central Nervous System disease (e.g., movement disorder, multiple sclerosis)\n* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms\n* Must not be scheduled to receive concurrent radiation treatment while receiving chemotherapy.\n* Must not be colorblind\n\nInclusion Criteria, Control Participants:\n\n* Must be female and within 5 years of the age of the subject receiving chemotherapy\n* Able to speak and read English\n* Give written informed consent\n* 21 years or older\n\nExclusion Criteria, Control Participants:\n\n* Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness\n* Must not be diagnosed with a neurodegenerative disease (e.g. Alzheimer's disease, Parkinson's disease)\n* Must not have Central Nervous System disease (e.g., movement disorder, multiple sclerosis)\n* Subjects could have had a TIA (transient ischemic attack) or stroke in the past if the TIA or stroke was greater than 1 year ago and the subject does not have any remaining symptoms\n* Must not have been diagnosed with cancer or previously have received chemotherapy\n* Must not be colorblind\n\nFor optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate"}, 'identificationModule': {'nctId': 'NCT03137095', 'briefTitle': 'Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Longitudinal Pilot Mechanistic Study of the Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants - Optional Sub-Study: Research Brain MRI', 'orgStudyIdInfo': {'id': '54027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Patient Participants', 'description': 'Female breast cancer patients receiving chemotherapy', 'interventionNames': ['Other: Cognitive testing', 'Other: Research Brain MRI']}, {'label': 'Healthy, age-matched, female participants', 'description': 'Healthy, female, age-matched participants', 'interventionNames': ['Other: Cognitive testing', 'Other: Research Brain MRI']}], 'interventions': [{'name': 'Cognitive testing', 'type': 'OTHER', 'description': 'computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 \\& 5.', 'armGroupLabels': ['Breast Cancer Patient Participants', 'Healthy, age-matched, female participants']}, {'name': 'Research Brain MRI', 'type': 'OTHER', 'description': 'Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.', 'armGroupLabels': ['Breast Cancer Patient Participants', 'Healthy, age-matched, female participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Alberti', 'role': 'CONTACT', 'email': 'Sara_Alberti@urmc.rochester.edu', 'phone': '585-273-3998'}, {'name': 'Tyler Holler', 'role': 'CONTACT', 'email': 'Tyler_Holler@urmc.rochester.edu', 'phone': '585-273-2950'}, {'name': 'Michelle C. Janelsins, PhD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'centralContacts': [{'name': 'Sara Alberti', 'role': 'CONTACT', 'email': 'Sara_Alberti@urmc.rochester.edu', 'phone': '585-273-3998'}, {'name': 'Tyler Holler', 'role': 'CONTACT', 'email': 'Tyler_Holler@urmc.rochester.edu', 'phone': '585-273-2950'}], 'overallOfficials': [{'name': 'Michelle C. Janelsins, Ph.D.,M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Michelle Janelsins, PhD, MPH', 'investigatorAffiliation': 'University of Rochester'}}}}