Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 11:48 AM
Study NCT ID:
NCT05451134
Status:
UNKNOWN
Last Update Posted:
2022-07-12
First Post:
2022-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D010235', 'term': 'Paraganglioma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002395', 'term': 'Catecholamines'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-09', 'studyFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline OGTT（oral glucose tolerance test）results to 6-12 months after surgery', 'timeFrame': 'Baseline, 6-12 months after surgery', 'description': 'OGTT results （including fasting blood glucose in the text, blood glucose results at 2 hours after oral administration of 75g glucose）at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia'}], 'secondaryOutcomes': [{'measure': 'random blood glucose results', 'timeFrame': 'baseline, 6-12 months after surgery', 'description': 'random blood glucose results at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia'}, {'measure': 'HbA1c', 'timeFrame': 'baseline, 6-12 months after surgery', 'description': 'HbA1c results at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia'}, {'measure': 'fasting blood glucose', 'timeFrame': 'baseline, 6-12 months after surgery', 'description': 'fasting blood glucose results at baseline and 6-12 months after surgery will be recorded to assess the effect of surgery on dysglycemia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pheochromocytoma', 'Paraganglioma', 'dysglycemia'], 'conditions': ['Pheochromocytoma', 'Paraganglioma']}, 'descriptionModule': {'briefSummary': "The investigators will retrospectively analyze the clinical data of consecutive patients with pheochromocytomas and paragangliomas admitted between January 2018 and June 2020. The clinical characteristics of patients with and without dysglycemia will be compared, and whether surgery could improve the patients'dysglycemia will be also investigated.", 'detailedDescription': "This retrospective cohort study will include all consecutive adult patients who underwent surgery for PHEOs and catecholamine-secreting PGLs from January 2018 to June 2020. Patients with recurrent PPGLs, those who required steroids after adrenalectomy, and those with inadequate clinical records were excluded. The patients' electronic medical files were reviewed. Patients with dysglycemia included those with diabetes, or impaired fasting glucose, or impaired glucose tolerance. Clinical history data such as age, sex, body mass index (BMI), the presence of preoperative symptoms, biochemical test results, and tumor characteristics, such as tumor diameters and locations were extracted and analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective cohort study will include all consecutive adult patients who underwent surgery for pheochromocytomas and paragangliomas from January 2018 to June 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years old\n* patients with surgical pathological diagnosis of pheochromocytomas and paragangliomas(PPGLs)\n\nExclusion Criteria:\n\n* recurrent PPGLs\n* patients who required steroids after adrenalectomy\n* patients with inadequate clinical records were excluded.'}, 'identificationModule': {'nctId': 'NCT05451134', 'briefTitle': 'Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Predictors and Outcomes of Dysglycemia in Pheochromocytoma and Paraganglioma', 'orgStudyIdInfo': {'id': '2022-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with dysglycemia', 'description': 'Patients with dysglycemia in the included subjects with pheochromocytoma and paraganglioma', 'interventionNames': ['Other: Catecholamines']}, {'label': 'patients without dysglycemia', 'description': 'Patients without dysglycemia in the included subjects with pheochromocytoma and paraganglioma', 'interventionNames': ['Other: Catecholamines']}], 'interventions': [{'name': 'Catecholamines', 'type': 'OTHER', 'description': 'Focus on whether catecholamine exposure is associated with dysglycemia in patients with pheochromocytoma and paraganglioma', 'armGroupLabels': ['patients with dysglycemia', 'patients without dysglycemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Xian-Liang Zhou', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xian-Liang Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Center for Cardiovascular Diseases; Fuwai Hospital, Chinese Academy of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}