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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast Cancer Patient Participants | Female breast cancer patients receiving chemotherapy |
| |
| Healthy, age-matched, female participants | Healthy, female, age-matched participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive testing | Other | computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function (memory, concentration, attentiveness) will be assessed by computerized cognitive assessments and associated with inflammation and neurotoxicity markers | Change scores from baseline will be computed for each cognitive measure as well as each mechanistic marker | During chemotherapy and 1 month post-chemotherapy; Approximately 3 - 5 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Research Brain MRI | 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 | After 4 cycles Adriamycin/Cytoxan (each cycle of AC is 14 days) and within 1 month post additional chemotherapy treatment |
Inclusion Criteria, Breast Cancer Patient Participants:
Exclusion Criteria, Breast Cancer Patient Participants:
Inclusion Criteria, Control Participants:
Exclusion Criteria, Control Participants:
For optional sub-study: MR safety assessed via Rochester Center for Brain Imaging Magnetic Resonance (MR) Safety Screening Form to confirm eligibility to participate
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Female breast cancer patients with a diagnosis of invasive non-metastatic breast cancer (stage I -IIIC) and age-matched, health female participants
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Alberti | Contact | 585-273-3998 | Sara_Alberti@urmc.rochester.edu | |
| Tyler Holler | Contact | 585-273-2950 | Tyler_Holler@urmc.rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michelle C. Janelsins, Ph.D.,M.P.H. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
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whole blood, serum, plasma, peripheral blood mononuclear cells (PBMC)
| Research Brain MRI | Other | Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6. |
|
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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