Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 5:02 PM
Study NCT ID:
NCT04937335
Status:
COMPLETED
Last Update Posted:
2021-06-24
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Craniopharyngioma With Tumoral Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003397', 'term': 'Craniopharyngioma'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'craniopharyngioma with tumoral hemorrhage', 'timeFrame': 'during the operation', 'description': 'Current study is a case-control study whose primary outcome is tumoral hemorrhage observed during the operation, which devided the craniopharyngioma patients into hemorrhage group and non-hemorrhage group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['craniopharyngioma', 'endocrine', 'risk factor', 'tumoral hemorrhage'], 'conditions': ['Craniopharyngioma', 'Apoplexy']}, 'descriptionModule': {'briefSummary': 'Clinical data of 185 consecutive patients receiving resective operation with a pathological diagnosis of craniopharyngioma in our hospital between January 2013 and February 2021 were collected. Among these patients, 18 of them were recognized as craniopharyngioma with tumoral hemorrhage during the operation.', 'detailedDescription': 'For each case, age, gender, smoking status, alcohol intake, past history, symptoms, blood pressure, blood cell count, blood biochemical tests, coagulation tests, hormone tests, radiological results, surgical treatment and the outcome at discharge were collected. The first test result after admission and before the operation was taken for the items of blood tests with multiple times in the analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with a pathological diagnosis of craniopharyngioma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receive resective operation with a pathological diagnosis of craniopharyngioma in our hospital\n* enter our hospital between January 2013 and February 2021\n\nExclusion Criteria:\n\n* have a non-craniopharyngioma or unverified pathological diagnosis at discharge\n* have received surgical or radiological treatment on the sellar region\n* receive treatment of coagulation modulation, immunosuppressive agents or chemotherapeutic drugs\n* combine with other clinical emergencies including acute myocardial infarction, cerebral stroke, trauma and sepsis at admission\n* have been diagnosed with other tumors, hematological diseases, autoimmune diseases, liver failure or renal failure'}, 'identificationModule': {'nctId': 'NCT04937335', 'briefTitle': 'Craniopharyngioma With Tumoral Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Clinical Features and Risk Factors of Craniopharyngioma With Tumoral Hemorrhage', 'orgStudyIdInfo': {'id': 'kaishu1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-hemorrhage group', 'description': 'Patients recognized as craniopharyngioma pathologically without tumoral hemorrhage observed during the operation'}, {'label': 'Hemorrhage group', 'description': 'Patients recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation', 'interventionNames': ['Other: intratumoral hemorrhage']}], 'interventions': [{'name': 'intratumoral hemorrhage', 'type': 'OTHER', 'description': 'Patients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group.', 'armGroupLabels': ['Hemorrhage group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kai Shu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data would remain confidential and would not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Kai Shu', 'investigatorAffiliation': 'Tongji Hospital'}}}}