Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 3:04 AM
Study NCT ID:
NCT07226466
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011788', 'term': 'Quality of Life'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples will be obtained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-06', 'studyFirstSubmitDate': '2025-11-06', 'studyFirstSubmitQcDate': '2025-11-06', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in serum Amyloid-beta peptide (Aβ)', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for Aβ over time will be reported'}, {'measure': 'Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotype', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for Aβ by APOE genotype over time will be reported'}, {'measure': 'Mean change of score on the European Organization for Research and Treatment of Cancer quality of life questionnaire - Brain Module (EORTC-QLQ-BN20)', 'timeFrame': 'Up to 18 months from date of first radiation dose', 'description': 'The EORTC QLQ-BN20 consists of 20 questions; seven single item symptom scales (headaches, seizures, drowsiness, hair loss, itchy skin, leg weakness and bladder control), along with four multi-item scales (future uncertainty, visual disorder, motor dysfunction and communication deficit). Raw scores for the QLQ-BN20 items are computed by calculating the mean of the items in each subscale, or the item for each individual and linearly transform the scores to a 0-100 scale. A higher score represents worse QOL for all QLQ-BN20 scales and single items.'}, {'measure': 'Mean change in serum Glial Fibrillary Acidic Protein (GFAP)', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for GFAP over time will be reported'}, {'measure': 'Mean change in serum Glial Fibrillary Acidic Protein (GFAP) by APOE genotype', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for GFAP by APOE genotype over time will be reported'}, {'measure': 'Mean change in serum Phosphorylated TAU (p-TAU)', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for p-TAU over time will be reported'}, {'measure': 'Mean change in serum Phosphorylated TAU (p-TAU) by APOE genotype', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for p-TAU by APOE genotype over time will be reported'}, {'measure': 'Mean change in serum Neurofilament Light Chain (NfL)', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for NfL over time will be reported'}, {'measure': 'Mean change in serum Neurofilament Light Chain (NfL) by APOE genotype', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in biomarker for NfL by APOE genotype over time will be reported'}, {'measure': 'Mean change in Brain Health Assessment by APOE genotype', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in of Brain Health Assessment by APOE genotype over time will be reported'}, {'measure': 'Mean change in Hippocampal Volume', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in Hippocampal Volume as measured by MRI over time will be reported'}, {'measure': 'Mean change in Hippocampal Volume by APOE genotype', 'timeFrame': 'Up to 12 months', 'description': 'Mean change in Hippocampal Volume as measured by MRI by APOE genotype over time will be reported'}], 'secondaryOutcomes': [{'measure': 'Change in scores on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) over time', 'timeFrame': 'Up to 18 months from date of first radiation dose', 'description': 'The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Tumor Adult', 'Brain Metastases From Solid Tumors', 'Brain Tumor, Primary', 'Brain Tumor']}, 'descriptionModule': {'briefSummary': 'This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\n1. Assess plasma biomarkers for Aβ, GFAP, phospho Tau, and NfL pre- and post-radiotherapy.\n2. Determine APOE genotype.\n3. Evaluate neuropsychiatric testing aligned with standard of care brain MRIs and serum markers.\n4. Measure brain morphometrics pre- and post-radiotherapy with standard of care brain MRIs.\n\nSECONDARY OBJECTIVES:\n\n1\\. Measure patient-reported quality of life changes pre- and post-radiotherapy using a standard University of California, San Francisco (UCSF) -approved questionnaire.\n\nOUTLINE:\n\nThis is a single-arm, non-randomized, open-label pilot study. Participants will be study duration spans 12 months post-brain radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with brain cancers receiving care at University of California, San Francisco (UCSF)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. \\>= 18 years old\n2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.\n3. Diagnosis of primary solid tumor and secondary involvement of the brain\n4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \\> 1 cm in max diameter.\n5. Candidate for standard of care / usual care (SOC) focused brain radiotherapy.\n6. No prior brain radiotherapy, including whole brain radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.\n8. Estimated life expectancy post-treatment of \\> 2 years.\n\nExclusion Criteria:\n\n1. Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).\n2. Diagnosis of memory disorder pre-treatment.\n3. Leptomeningeal disease or disease involving either hippocampus."}, 'identificationModule': {'nctId': 'NCT07226466', 'briefTitle': 'Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer', 'orgStudyIdInfo': {'id': '249213'}, 'secondaryIdInfos': [{'id': 'NCI-2025-01532', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with Brain Tumor Receiving Radiotherapy', 'description': 'The study entails longitudinal assessment of plasma biomarkers (Aβ, GFAP, phospho Tau, NfL), determination of APOE genotype, neuropsychiatric testing Brain Health Assessment test (BHA), a clinically validated neurocognitive battery compiling metrics on memory and language), and brain morphometric measurements synchronized with standard of care brain MRIs.', 'interventionNames': ['Procedure: Blood sample', 'Procedure: Brain magnetic resonance imaging (MRI)', 'Procedure: Brain Health Assessment', 'Radiation: Quality of Life (QoL) Questionnaire']}], 'interventions': [{'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Blood sample will be collected', 'armGroupLabels': ['Adults with Brain Tumor Receiving Radiotherapy']}, {'name': 'Brain magnetic resonance imaging (MRI)', 'type': 'PROCEDURE', 'description': 'Brain MRI will be performed during the course of data collection', 'armGroupLabels': ['Adults with Brain Tumor Receiving Radiotherapy']}, {'name': 'Brain Health Assessment', 'type': 'PROCEDURE', 'description': 'Brain Health Assessment will be performed during the course of data collection', 'armGroupLabels': ['Adults with Brain Tumor Receiving Radiotherapy']}, {'name': 'Quality of Life (QoL) Questionnaire', 'type': 'RADIATION', 'description': 'QoL questionnaire will be given to participants during the course of data collection', 'armGroupLabels': ['Adults with Brain Tumor Receiving Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jean Nakamura, MD', 'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '877-827-3222'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Jean Nakamura, MD', 'role': 'CONTACT', 'email': 'Jean.Nakamura@ucsf.edu', 'phone': '(415) 514-4997'}], 'overallOfficials': [{'name': 'Jean Nakamura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}