Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT04454268
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intracranial Hydatid Cyst
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-06-27', 'studyFirstSubmitQcDate': '2020-06-27', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients who haven total removal of intracranial cyst', 'timeFrame': '7 years', 'description': 'degree of consciousness incomplete extirpation without removal without neurological deficit 0 space'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Neoplasm']}, 'descriptionModule': {'briefSummary': 'Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the treatment of choice, resulting in most cases to a complete recovery.', 'detailedDescription': 'Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon, Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less commonly, Egypt)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intracranial hydatid cyst\n\nExclusion Criteria:\n\n* Arachnoid cysts\n* conservative treatment'}, 'identificationModule': {'nctId': 'NCT04454268', 'briefTitle': 'Intracranial Hydatid Cyst', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Intracranial Hydatid Cyst: Series of 8 Cases', 'orgStudyIdInfo': {'id': 'Intracranial Hydatid Cyst'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'hydatid cyst', 'interventionNames': ['Procedure: cyst extirpation']}], 'interventions': [{'name': 'cyst extirpation', 'type': 'PROCEDURE', 'description': 'complete removal of the cyst without rupture', 'armGroupLabels': ['hydatid cyst']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of neurosurgery', 'investigatorFullName': 'ahmed salaheldin mohammed saro', 'investigatorAffiliation': 'Sohag University'}}}}