Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT04306432
Status:
RECRUITING
Last Update Posted:
2021-12-02
First Post:
2020-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Function After Radiation Therapy for Primary Brain Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D000071066', 'term': 'Patient Reported Outcome Measures'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D019538', 'term': 'Health Care Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006302', 'term': 'Health Services Research'}, {'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D063868', 'term': 'Patient Outcome Assessment'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2034-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-19', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impairment of verbal learning and memory as assessed by the HVLT-r test', 'timeFrame': '10 Years', 'description': 'Examined by the Hopkins Verbal Learning Test revised. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24)'}], 'secondaryOutcomes': [{'measure': 'Processing speed I', 'timeFrame': '10 years', 'description': 'Examined by the Trail making Test part A (TMT\\_A). Outcome for TMT\\_A is time in seconds (0-120 seconds).'}, {'measure': 'Processing speed II', 'timeFrame': '10 years', 'description': 'Examined by the Coding from Wechsler Adult Intelligence Scale (WAIS-IV). Outcome for Coding is number of correct (within 2 minutes) (0-100)'}, {'measure': 'Attention and working memory', 'timeFrame': '10 years', 'description': 'Examined by Wechsler Adult Intelligence Scale (WAIS\\_IV\\_digit\\_span). Outcome on WAIS digit span is number of correct (0-36)'}, {'measure': 'Verbal learning and memory', 'timeFrame': '10 years', 'description': 'Examine by the Hopkins Verbal Learning Test revised (HVLT-r) - total and delayed. Outcome is number of correct words (0-24)'}, {'measure': 'Verbal fluency', 'timeFrame': '10 years', 'description': 'Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter\\_S. Outcome is number of words produced in 1 minute (0-100)'}, {'measure': 'Executive function I', 'timeFrame': '10 years', 'description': 'Examined by Trail making Test part B (TMT\\_B). Outcome for TMT\\_B is time in seconds (0-300).'}, {'measure': 'Executive function II', 'timeFrame': '10 years', 'description': 'Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120)'}, {'measure': 'Global Health - Quality of life', 'timeFrame': '10 years', 'description': 'Assessed by questionnaire; European organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. The total score is a number (0-100)'}, {'measure': 'Side effects to radiation therapy', 'timeFrame': '10 years', 'description': 'Assessed by EORTC Brain Neoplasm Questionnaire, BN20 (an addition to QLQ-C30 mentioned above) in order to measure side effects to radiation therapy for a brain tumour. the score is a number (0-100)'}, {'measure': 'Quality of Sleep', 'timeFrame': '10 years', 'description': 'Assessed by questionnaire: Pittsburgh Sleep Quality INDEX, (PSQI) in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy. Outcome is a number (0-33)'}, {'measure': 'Fatigue', 'timeFrame': '10 years', 'description': 'Assessed by questionnaire: Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy. Outcome is a number (0-52)'}, {'measure': 'Depression/Anxiety', 'timeFrame': '10 years', 'description': 'Assessed by questionnaire: Hospital anxiety and depression Scale (HADS) in order to explore level of depression and anxiety in patients treated with radiation therapy for their brain tumour. Outcome is a number (0-56)'}, {'measure': "Patient's Assessment of Own Functioning", 'timeFrame': '10 years', 'description': "Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function. Outcome is a number (35-210)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain tumour', 'Radiation therapy', 'Cognitive function', 'Hippocampus', 'Patient reported outcomes'], 'conditions': ['Primary Brain Tumour', 'Radiation Toxicity', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.', 'detailedDescription': "RT is fundamental in the treatment of primary brain tumours. RT contributes to improved local control and prolonged progression-free survival in patients with a broad range of tumour types. Irradiation to the normal brain may lead to cognitive impairments. Clarifying the nature and severity of impairment in adult RT-treated brain tumour patients, including region-specific effects, are important for optimal utilization of novel conformal RT technologies such as proton therapy.\n\nThe study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Center of Particle Therapy and the four Neuro Oncology Centers in Denmark.\n\nThe patients will be assessed with a comprehensive battery of standardized cognitive tests and complete a questionnaire (PRO's). They will do this prior to RT treatment and 1, 3, 5 and 10 years afterwards. The PRO's includes measures on quality of life, fatigue, sleep, depression, anxiety, and socio demographics. The standardized tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV. The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.\n\nThis study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients will be diagnosed with a primary brain tumour and referred to radiation therapy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older and Danish speaking.\n* Performance status WHO 0-2\n* Capable of cooperating on testing\n* Tumour histology (WHO 2016 classification) of the following types: anaplastic astrocytoma (IDH mutant), diffuse astrocytoma (IDH-mutant), gemistocytic astrocytoma (IDH mutant), diffuse astrocytoma (NOS), oligodendroglioma, meningioma, medulloblastoma (NOS), pituitary adenoma, other brain tumours including skull base sarcomas\n\nExclusion Criteria:\n\n* Glioblastoma\n* Performance status 3-4 (Karnofsky Performances of 60 or less)'}, 'identificationModule': {'nctId': 'NCT04306432', 'briefTitle': 'Cognitive Function After Radiation Therapy for Primary Brain Tumours', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Cognitive Function After Radiation Therapy for Primary Brain Tumours', 'orgStudyIdInfo': {'id': 'DNOG-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cognitive tests and Patient Reported Outcomes', 'type': 'OTHER', 'description': 'Each patient will undergo cognitive tests and questionnaires'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Capital Region', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Aida Muhic', 'role': 'CONTACT', 'email': 'aida.muhic@regionh.dk', 'phone': '+45 35456942'}], 'facility': 'Department of Oncology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '8200', 'city': 'Aarhus', 'state': 'Region Midt', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Morten Høyer', 'role': 'CONTACT', 'email': 'morthoey@rm.dk', 'phone': '+452328 2823'}, {'name': 'Lene Haldbo-Classen', 'role': 'CONTACT', 'email': 'lenhaldb@rm.dk', 'phone': '+45 2334 2761', 'phoneExt': '+4523342761'}, {'name': 'Petra Witt', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Danish Center for Particel Therapy', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8200', 'city': 'Aarhus', 'state': 'Region Midt', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Slavka Lucakova', 'role': 'CONTACT', 'email': 'slvkluka@rm.dk', 'phone': '+45 3027 2470'}, {'name': 'Lene Haldbo-Classen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Oncology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '9000', 'city': 'Aalborg', 'state': 'Region Nord', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Charlotte Haslund', 'role': 'CONTACT', 'email': 'cah@rn.dk', 'phone': '+45 97661414'}], 'facility': 'Department of Oncology, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '5000', 'city': 'Odense', 'state': 'Region Syd', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Rikke Dahlrot', 'role': 'CONTACT', 'email': 'rikke.dahlrot@rsyd.dk', 'phone': '+45 26242142'}], 'facility': 'Department of Oncology, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Morten Høyer, MD', 'role': 'CONTACT', 'email': 'morthoey@rm.dk', 'phone': '+45 2328 2823'}, {'name': 'Lene Haldbo-Classen, MD', 'role': 'CONTACT', 'email': 'lenhaldb@rm.dk', 'phone': '+4523342761'}], 'overallOfficials': [{'name': 'Lene Haldbo-Classen, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}