Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-25 @ 12:47 PM
Study NCT ID:
NCT06435195
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission', 'timeFrame': 'Postoperative one week and extends to the latest follow-up, estimated at up to 3 years', 'description': 'Hormonal normalization and free of pathologies'}], 'secondaryOutcomes': [{'measure': 'Disease Comorbidities', 'timeFrame': 'From patient admission to an evaluation period extending up to the latest follow-up, estimately up to 3 years', 'description': 'Systemic changes accompanied with Pituitary Complex and Rare Diseases'}, {'measure': 'Postoperative complications', 'timeFrame': 'Postoperative one week and extends to the latest follow-up, estimated at up to 3 years', 'description': 'adverse events or medical issues that arise after a surgical procedure on the pituitary diseases.These complications can include various problems such as bleeding, infection, hormonal imbalances, cerebrospinal fluid leaks, vision changes, or neurological deficits'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pituitary Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to systematically describe the clinical characteristics and outcomes of patients with pituitary complex and rare diseases at Peking Union Medical College Hospital. The main questions it aims to answer are:\n\n* What are the influencing factors and rates of remission?\n* What are the comorbidities associated with these diseases?\n* What are the perioperative events, radiological findings, and pathological features?\n\nResearchers will compare different patient groups to see if there are significant differences in these outcomes.\n\nParticipants will:\n\n* Undergo detailed clinical evaluations.\n* Provide medical history and data for analysis.\n* Participate in follow-up assessments to monitor disease progression and treatment outcomes.', 'detailedDescription': 'The study aims to provide a comprehensive analysis of pituitary complex and rare diseases at Peking Union Medical College Hospital. By leveraging a large cohort, the research will explore various clinical characteristics and outcomes. Specifically, the study will examine influencing factors and rates of remission, the presence of comorbidities, and perioperative events. Additionally, it will evaluate radiological findings and pathological features to better understand these conditions. Through this detailed investigation, the study seeks to enhance knowledge and inform clinical practice regarding the management and prognosis of pituitary complex and rare diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are diagnosed with Pituitary Complex and Rare Diseases at Peking Union Medical College Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with rare sellar diseases including but not limited to pituitary adenomas (such as Thyrotropin-secreting pituitary adenomas, GH-secreting adenomas), craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases\n* Detailed medical history, including clinical symptoms, treatment plans and follow-up outcomes\n\nExclusion Criteria:\n\n* Incomplete medical records, especially missing key imaging diagnostic results\n* Patients with coexisting primary central nervous system diseases unrelated to sellar region diseases (such as severe traumatic brain injury)\n* Patients whose sellar region pathological diagnosis was changed or overturned during the follow-up period"}, 'identificationModule': {'nctId': 'NCT06435195', 'briefTitle': 'Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Clinical Characteristics and Analysis of Pituitary Complex and Rare Diseases', 'orgStudyIdInfo': {'id': 'K5112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pituitary Complex and Rare Diseases', 'description': "The Pituitary Complex and Rare Diseases cohort consists of patients diagnosed with various pituitary disorders, including but not limited to pituitary adenomas, craniopharyngiomas, Rathke's cleft cysts, sellar region germ cell tumors, cavernous sinus syndrome, and other diseases. Patients requiring surgical resection or biopsy of pituitary pathologies will undergo transsphenoidal surgery or craniotomy.", 'interventionNames': ['Procedure: Surgical Removal', 'Procedure: Biopsy']}], 'interventions': [{'name': 'Surgical Removal', 'type': 'PROCEDURE', 'description': 'Resection of pituitary pathologies.', 'armGroupLabels': ['Pituitary Complex and Rare Diseases']}, {'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Taking a small tissue or liquid sample from the pituitary pathologies and the affected area for examination and diagnosis', 'armGroupLabels': ['Pituitary Complex and Rare Diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Yao, MD', 'role': 'CONTACT', 'email': 'yaoyong@pumch.cn', 'phone': '+8669152530'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yong Yao, MD', 'role': 'CONTACT', 'email': 'yaoyong@pumch.cn', 'phone': '+8669152530'}], 'overallOfficials': [{'name': 'Yong Yao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}