Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606535
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
ENDO-BRAIN Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENDO-BRAIN Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDO-BRAIN
Brief Summary:
The principal aim of this prospective observational study is to investigate the cognitive function of breast cancer patients that use AI comparing it with age-matched healthy controls utilizing cognitive assessments and functional magnetic resonance imaging fMRI Additionally the project seeks to establish correlations between cognitive function and other estrogen deprivation symptoms including vasomotor symptoms and to evaluate a possible correlation with endothelial damage studied through Angio Optical Coherent Tomography angio OCT
Patients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic After informed consent the will be asked for detailed demographic data medical oncological and gynecological history Hypoestrogenism symptoms will be collected through validated questionnaires The cognitive assessment will be performed on the same day by trained staff The fMRI and angioOCT will be booked and performed depending on patient and clinic availability
Patients will be recruited during follow up visits at the iatrogenic menopause outpatient clinic After informed consent the will be asked for detailed demographic data medical oncological and gynecological history Hypoestrogenism symptoms will be collected through validated questionnaires The cognitive assessment will be performed on the same day by trained staff The fMRI and angioOCT will be booked and performed depending on patient and clinic availability
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None