Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-28 @ 6:43 PM
Study NCT ID:
NCT04863456
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of QoL (Quality of Life, EQ-5D) for the first surgery', 'timeFrame': 'baseline (before the first surgery), 2 years after the first surgery', 'description': 'EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years'}, {'measure': 'Change of QoL (Quality of Life, EQ-5D) for the second intervention', 'timeFrame': 'baseline (before the second intervention), 3 months after the second intervention', 'description': 'EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months'}], 'secondaryOutcomes': [{'measure': 'Change of Visual Acuity statue', 'timeFrame': 'baseline (before the first surgery), 2 years after the first surgery', 'description': "Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years"}, {'measure': 'Change of Visual Field statue', 'timeFrame': 'baseline (before the first surgery), 2 years after the first surgery', 'description': 'Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years'}, {'measure': 'Change of Hormone Replacement Therapy', 'timeFrame': 'baseline (before the first surgery), 2 years after the first surgery', 'description': 'Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years'}, {'measure': 'Extent of resection', 'timeFrame': 'baseline (before the first surgery), 2 years after the first surgery', 'description': 'Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pituitary adenoma', 'treatment strategy', 'Hypothalamus'], 'conditions': ['Pituitary Adenoma']}, 'descriptionModule': {'briefSummary': 'Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)', 'detailedDescription': 'There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement\n* Informed consent\n\nExclusion Criteria:\n\n* No follow-up possible\n* Emergency surgery without informed consent'}, 'identificationModule': {'nctId': 'NCT04863456', 'briefTitle': 'Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement', 'orgStudyIdInfo': {'id': '[2021]IEC-J(227)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIPA group of Puget grade 1', 'description': 'the tumor abuting or displacing the hypothalamus in the preoperative MR images', 'interventionNames': ['Procedure: Total resection', 'Procedure: Staged resection', 'Procedure: Subtotal resection followed by stereotactic radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'HIPA group of Puget grade 2', 'description': 'hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images', 'interventionNames': ['Procedure: Total resection', 'Procedure: Staged resection', 'Procedure: Subtotal resection followed by stereotactic radiation therapy']}], 'interventions': [{'name': 'Total resection', 'type': 'PROCEDURE', 'description': 'Total resection of HIPA in a single surgery', 'armGroupLabels': ['HIPA group of Puget grade 1', 'HIPA group of Puget grade 2']}, {'name': 'Staged resection', 'type': 'PROCEDURE', 'description': 'HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date', 'armGroupLabels': ['HIPA group of Puget grade 1', 'HIPA group of Puget grade 2']}, {'name': 'Subtotal resection followed by stereotactic radiation therapy', 'type': 'PROCEDURE', 'description': 'HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy', 'armGroupLabels': ['HIPA group of Puget grade 1', 'HIPA group of Puget grade 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tao Huang, PhD, MD', 'role': 'CONTACT', 'email': 'neuroht@hust.edu.cn', 'phone': '027-85350819'}], 'overallOfficials': [{'name': 'Tao Huang, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}