Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-05 @ 5:53 PM
Study NCT ID:
NCT04635657
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2020-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Status After Removal of Skull Base Meningioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-22', 'studyFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2020-11-13', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Surgical comorbidities based on quality of life questionnaire PROMIS-29', 'timeFrame': '12 months', 'description': 'Assessment of preoperative and postoperative comorbidities and their effects on cognitive function post-operatively. Co-morbidities will be based on clinical outcomes evaluated by the primary investigator, co-investigators and the speech language pathology team.'}], 'primaryOutcomes': [{'measure': 'Overall cognitive function', 'timeFrame': '12 months', 'description': 'Cognitive function will be compared at baseline and at one year post-operatively.'}], 'secondaryOutcomes': [{'measure': 'Cognitive function based on surgical approach using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': '12 months', 'description': 'Patients divided by approach and overall cognitive function will be evaluated.'}, {'measure': 'Cognitive function based on tumor location using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)', 'timeFrame': '12 months', 'description': 'Patients will be divided by tumor location and cognitive function will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningioma', 'Skull Base Meningioma', 'Frontal Meningioma', 'Temporal Meningioma', 'Cognitive Impairment', 'Cognitive Decline', 'Post-Surgical Cognition']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospectively enrolling trial is to assess long-term cognitive outcomes of patients undergoing surgery for resection of a meningioma associated with the frontal and temporal lobes.', 'detailedDescription': 'This study will look at patients who are undergoing resection of a skull based meningioma, located in the frontal or temporal lobe, via craniotomy or via endoscopic endonasal approach. The study will compare cognitive function at baseline, at six weeks postoperatively and at one year postoperatively. The cognitive testing being done at baseline will be a clinical care set of assessments done by the speech language pathology team and will include the RBANS tests, the MoCA, PROMIS-29, and NeuroQOL-Cognitive Functions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between 18 years of age and 89 years of age will be eligible for this study. Patients undergoing a resection of a meningioma located in the frontal or temporal lobes via craniotomy or endoscopic endonasal surgery for clinical purposes will be included. Should a patient have a previous surgical removal of a meningioma, they will still be included. However, all patients having undergone previous radiation to the brain, for any reason, will not be included in the study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has a meningioma associated with the frontal or temporal lobes\n* Subject is scheduled to undergo open craniotomy or Endoscopic Endonasal surgery\n* Subject is 18 years of age or older\n* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent\n* Previous surgery will not exclude the patient as a new baseline cognitive evaluation will occur.\n\nExclusion Criteria:\n\n* Patient is a prisoner\n* Patient is 90 years of age or older\n* Pregnant women\n* Previous radiation to the brain"}, 'identificationModule': {'nctId': 'NCT04635657', 'briefTitle': 'Cognitive Status After Removal of Skull Base Meningioma', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Pre and Post-Operative Cognitive Status in Patients Undergoing Surgery for Resection of Meningioma Associated With the Frontal and Temporal Lobes', 'orgStudyIdInfo': {'id': '2019H0340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Meningioma Group', 'description': 'This group will include all patients in the study, regardless of location (frontal or temporal lobe) or surgical approach (endoscopic endonasal or craniotomy). Fifty patients will be included in the cohort', 'interventionNames': ['Other: Long-term Cognitive testing']}], 'interventions': [{'name': 'Long-term Cognitive testing', 'type': 'OTHER', 'description': 'These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.', 'armGroupLabels': ['Meningioma Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Frost, BS', 'role': 'CONTACT', 'email': 'Megan.Frost@osumc.edu', 'phone': '614-685-8622'}, {'name': 'Uchechi Okafor, BS', 'role': 'CONTACT', 'email': 'Uchechi.Okafor@osumc.edu', 'phone': '614-293-4876'}, {'name': 'Daniel Prevdello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Megan Frost, BS', 'role': 'CONTACT', 'email': 'Megan.Frost@osumc.edu', 'phone': '614-685-8622'}, {'name': 'Uchechi Okafor, BS', 'role': 'CONTACT', 'email': 'Uchechi.Okafor@osumc.edu', 'phone': '614-293-4876'}], 'overallOfficials': [{'name': 'Daniel Prevedello, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There will not be sharing of individual participant data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Daniel M. Prevedello', 'investigatorAffiliation': 'Ohio State University'}}}}