Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 1:12 PM
Study NCT ID:
NCT00152659
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2005-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing Criteria for Cortical Resections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006650', 'term': 'Histocompatibility Testing'}, {'id': 'D008403', 'term': 'Mass Screening'}], 'ancestors': [{'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2005-09-07', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure electrical activity in tissue sample', 'timeFrame': 'at tissue aremoval time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Tumor', 'Surgery', 'Brain'], 'conditions': ['Epilepsy', 'Tumor']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ramirez J-M, Koch H, Pena F, Drongelen W van, Tryba AK, Parkis MA, Loweth JA, Hecox KE, Kohrman MH, Frim DM, Chico MS, Marcuccilli CJ (2003) - In vitro electrophysiological differences between least and most abnormal tissue obtained from pediatric patients with intractable epilepsy. Epilepsia 44, Suppl 9: 245-246'}, {'type': 'BACKGROUND', 'citation': 'Marcuccilli CJ, Koch H, Pena F, Drongelen W van, Tryba AK, Parkis MA, Hecox KE, Kohrman MH, Frim DM, OConnor SE, Chico MS, Ramirez J-M (2003) - Rational pharmacotherapy: relationship between in vitro electrophysiology and clinical measures. Epilepsia 44, Suppl 9: 244-245'}, {'type': 'BACKGROUND', 'citation': 'Drongelen W van, Koch H, Marcuccilli CJ, Viemari J, Tryba AKH, Loweth JA, Ramirez J-M, Elsen F (2004) - Persistent sodium current plays a critical role in the generation of slow oscillations in vitro neocortex brain slices of mice and humans. Abstract Soc Neuroscience'}, {'type': 'BACKGROUND', 'citation': 'Drongelen W van, Doren EL, Koch H, Marcuccilli CJ, Ramirez J-M, Elsen FP (2005) - Characterization of the persistent sodium current in neocortical networks of mice and humans. Abstract Washington DC: Society for Neuroscience'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain.', 'detailedDescription': 'The purpose of this study is to study how disease processes like tumors or epilepsy spread in the brain. During surgery small pieces of abnormal (unusual) brain tissue may be removed. We analyze these specimens using more advanced microscopic and electrophysiologic techniques than are usually applied to such tissue specimens. In addition, some tissues can be maintained in laboratory conditions to allow analysis over the longer term. No extra brain tissue is taken to perform these studies. The tissue analysis is performed by the research team and are compared to the routine (normal) electrical recordings that are taken during this type of brain surgery. Currently there are no instructions telling a doctor how much brain tissue should be cut out to prevent the spread of tumors or epilepsy. We are hoping that the results of this study help us to better know how much brain tissue needs to be removed to prevent the spread of tumors or epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical candidates with epilepsy or brain tumor(s)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical candidates with epilepsy or brain tumor(s)'}, 'identificationModule': {'nctId': 'NCT00152659', 'briefTitle': 'Developing Criteria for Cortical Resections', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Developing Functional and Structural Criteria for Cortical Resections', 'orgStudyIdInfo': {'id': '9538'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tissue sample (procedure/screening)', 'type': 'PROCEDURE', 'description': 'Tissue sampling'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "The University of Chicago Hospitals, The University of Chicago Comer Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Wim van Drongelen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}