Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-01 @ 12:04 PM
Study NCT ID:
NCT06606535
Status:
RECRUITING
Last Update Posted:
2024-09-23
First Post:
2024-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients
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': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-18', 'studyFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive assessment', 'timeFrame': 'Once, at enrollment.', 'description': 'The principal aim of this project is to investigate the cognitive function of breast cancer patients that use Aromatase Inhibitors, comparing it with age-matched healthy controls, utilizing cognitive assessment and fMRI.\n\n* neuropsychological battery composed of the i) prose recall test, ii) trail making test A and B, iii) digit span backward and forward and iv) the symbol digit modalities test\n* 3T MRI (Siemens Prisma): 3D sagittal T2-FLAIR; 3D MP2RAGE; T2\\* gradient echo-planar imaging under resting condition; twice-refocused spin echo echo-planar imaging sequence for multi-shell diffusion-weighted images'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['breast cancer', 'cognitive side effects', 'hypoestrogenism', 'ovarian function suppression', 'aromatase inhibitor'], 'conditions': ['Cognitive Side Effects of Cancer Therapy', 'Hypoestrogenism']}, 'referencesModule': {'references': [{'pmid': '28267750', 'type': 'BACKGROUND', 'citation': 'Menning S, de Ruiter MB, Veltman DJ, Boogerd W, Oldenburg HS, Reneman L, Schagen SB. Changes in brain activation in breast cancer patients depend on cognitive domain and treatment type. PLoS One. 2017 Mar 7;12(3):e0171724. doi: 10.1371/journal.pone.0171724. eCollection 2017.'}, {'pmid': '28177081', 'type': 'BACKGROUND', 'citation': 'Chen X, He X, Tao L, Li J, Wu J, Zhu C, Yu F, Zhang L, Zhang J, Qiu B, Yu Y, Wang K. The Working Memory and Dorsolateral Prefrontal-Hippocampal Functional Connectivity Changes in Long-Term Survival Breast Cancer Patients Treated with Tamoxifen. Int J Neuropsychopharmacol. 2017 May 1;20(5):374-382. doi: 10.1093/ijnp/pyx008.'}]}, 'descriptionModule': {'briefSummary': '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).\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a monocentric study, taking place in an university hospital, which is a referral point for both oncology and neurology.\n\nCases are recruited from the iatrogenic menopause outpatient clinic. This is a dedicated outpatient clinic for the gynecological follow up of cancer survivors, including breast cancer patients undergoing adjuvant endocrine therapy. It is part of the oncofertility pathway of the institution, it is run by doctors with specific expertise in reproductive endocrinology, fertility and menopause. The clinic is accessed by all patients, not only the symptomatic ones, for yearly follow ups. Healthy controls are recruited from the gynecological, neurological or ophthalmological outpatient clinics.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast cancer patients undergoing endocrine adjuvant therapy with AI, with or without GnRH agonists, depending on menopause status at diagnosis (cases only)\n* At least 18 years old\n* Good comprehension of oral and written Italian language\n\nExclusion Criteria:\n\n* incomplete ovarian suppression (cases)\n* previous neoplastic diseases other than the presently treated breast cancer for cases\n* known neurological or psychiatric disorders\n* use of hormonal contraception or hormonal replacement therapy (controls)'}, 'identificationModule': {'nctId': 'NCT06606535', 'acronym': 'ENDO-BRAIN', 'briefTitle': 'ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Policlinico San Martino'}, 'officialTitle': 'ENDO-BRAIN: Effects of Endocrine Adjuvant Therapy with Aromatase Inhibitors on the Cognitive Function of Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'ENDO-BRAIN'}, 'secondaryIdInfos': [{'id': 'DB id 13624', 'type': 'OTHER', 'domain': 'regional IRB (CERLiguria)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Breast cancer patients undergoing endocrine adjuvant therapy with Aromatase Inhibitors (+ GnRH analogues if they are premenopausal)', 'interventionNames': ['Diagnostic Test: validated questionnaires', 'Diagnostic Test: functional MRI', 'Diagnostic Test: Optical Coherent Tomography Angiography']}, {'label': 'Controls', 'description': 'Healthy age-matched women who are not using hormonal contraception or hormonal replacement therapy at the time of the study.', 'interventionNames': ['Diagnostic Test: validated questionnaires', 'Diagnostic Test: functional MRI', 'Diagnostic Test: Optical Coherent Tomography Angiography']}], 'interventions': [{'name': 'validated questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'Validated questionnaires for climacteric symptoms', 'armGroupLabels': ['Cases', 'Controls']}, {'name': 'functional MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'functional MRI', 'armGroupLabels': ['Cases', 'Controls']}, {'name': 'Optical Coherent Tomography Angiography', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['OCT angiography'], 'description': 'OCT angiography, macular and peripapillary scans', 'armGroupLabels': ['Cases', 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'state': 'GE', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudia Massarotti, Dr', 'role': 'CONTACT', 'email': 'claudia.massarotti@unige.it', 'phone': '0039 + 0105555845'}, {'name': 'Claudia Massarotti, Dr', 'role': 'CONTACT'}], 'facility': 'IRCCS Ospedale Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'centralContacts': [{'name': 'Claudia Massarotti, Dr', 'role': 'CONTACT', 'email': 'claudia.massarotti@unige.it', 'phone': '0039 + 0105555845'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Genova', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Claudia Massarotti', 'investigatorAffiliation': 'Ospedale Policlinico San Martino'}}}}