Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04414020
Status:
UNKNOWN
Last Update Posted:
2020-06-04
First Post:
2020-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors
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': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-30', 'studyFirstSubmitDate': '2020-05-22', 'studyFirstSubmitQcDate': '2020-05-30', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With craniotomy-Related Adverse Events', 'timeFrame': '3 months', 'description': 'Degree of microscopic cellular injury and brain odema in brain biopsy'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with neuronal deficit', 'timeFrame': '2 months', 'description': 'Sensory, motor or autonomic dysfunction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Progesterone', 'brain tumor', 'Neuronal biopsy'], 'conditions': ['Diffuse Traumatic Cerebral Edema']}, 'descriptionModule': {'briefSummary': 'Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty', 'detailedDescription': 'Progesterone is a natural neurosteroid that we are trying to use to impede both direct neuronal injury cauesd by and indirectly by surgical trauma. Progesterone can decreas vasogenic brain oedema. Our primary outcome is to ameliorate microscopic cytoplasmic injury and decrease brain oedema exploited by biopsy from brain tumor interface. Exclusion criteria demonstratd as refusal to participate in the trial , emergency craniotomy, recurrent brain tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All elective brain tumors elligible for craniotomy\n\nExclusion Criteria:\n\n* Refusal to participare\n* Emergency craniotomy'}, 'identificationModule': {'nctId': 'NCT04414020', 'briefTitle': 'Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors', 'orgStudyIdInfo': {'id': '623-4/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group receiving conventional treatment without progesterone'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'progesterone group', 'description': '1mg pregesterone intramusculer given 7 days pre and post operative , Biopsy was achieved from brain tumor interface', 'interventionNames': ['Drug: Progesteron']}], 'interventions': [{'name': 'Progesteron', 'type': 'DRUG', 'description': 'intramusculer progesterone', 'armGroupLabels': ['progesterone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6115', 'city': 'Al Minyā', 'state': 'Abohelal', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mina raouf, MD', 'role': 'CONTACT', 'email': 'Drmina2015@gmail.com', 'phone': '01015752424'}, {'name': 'omaima mohammad, MD', 'role': 'CONTACT', 'email': 'Omayamshehata@yahoo.com', 'phone': '01061762894'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 29.74446, 'lon': 31.29917}}, {'zip': '6115', 'city': 'Minya', 'state': 'Abohelal', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'mina raouf, MD', 'role': 'CONTACT', 'email': 'Drmina2015@gmail.com', 'phone': '01015752424'}, {'name': 'omaima mohammad, MD', 'role': 'CONTACT', 'email': 'Omayamshehata@yahoo.com', 'phone': '01061762894'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Mina Raouf, MD', 'role': 'CONTACT', 'email': 'drmina2015@gmail.com', 'phone': '01015752424'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Mina Maher', 'investigatorAffiliation': 'Ministry of Health and Population, Egypt'}}}}