Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02427295
Status:
UNKNOWN
Last Update Posted:
2015-04-28
First Post:
2015-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'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': 'D015282', 'term': 'Octreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2015-02-04', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)', 'timeFrame': 'Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative'}, {'measure': 'The time taken to IGF-1 normalization in each group.', 'timeFrame': 'Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative'}], 'secondaryOutcomes': [{'measure': 'GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose', 'timeFrame': 'Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative'}, {'measure': 'Clinical symptom and sign with AcroQoL questionnaire', 'timeFrame': 'Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative'}, {'measure': 'Sleep quality and disturbance with written questionnaire', 'timeFrame': 'Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative'}, {'measure': 'fasting glucose , postprandial glucose', 'timeFrame': 'Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.'}, {'measure': 'insulin', 'timeFrame': 'Change from pre-operative in insulin at 36 months post-operative.'}, {'measure': 'HbA1c', 'timeFrame': 'change from pre-operative in HbA1c at 36 months post-operative.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acromegaly']}, 'descriptionModule': {'briefSummary': 'Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.', 'detailedDescription': 'Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited.\n\nThe eligible patient population will consist of 30 adult, male and female patient with Age 18 or older.\n\n* Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15\n* Number of Centers: 1 (single center)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 or older.\n2. Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI, meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly) and with typical acromegalic features.\n3. No prior use of somatostatin analogues.\n4. Adequate hepatic and renal function\n5. Provision of a signed written informed consent\n\nExclusion Criteria:\n\n1. Severe co-morbid illness such as untreatable other malignancy and/or active infections.\n2. Pregnant or lactating women\n3. Hypersensitivity to Sandostatin or any component of the formulation.'}, 'identificationModule': {'nctId': 'NCT02427295', 'acronym': 'acromegaly', 'briefTitle': 'Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Long-term (up to 3 Years) Clinical and Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues: Open-labeled, Prospective, Parallel Group Study', 'orgStudyIdInfo': {'id': 'CSMS995BKR08T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 2: Surgery + Medical treatment', 'description': 'MRI : residual tumor 6 months post-op : IGF-1 \\>600 ng/ml\n\nmedical treatment : Sandostatin (Octreotide Acetate)', 'interventionNames': ['Drug: Sandostatin (Octreotide Acetate)']}, {'type': 'NO_INTERVENTION', 'label': 'Group 3 : Rescue group', 'description': 'If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)'}, {'type': 'NO_INTERVENTION', 'label': 'Gruop1 : Surgery only group', 'description': 'MRI : without residual tumor 6months post-operation\n\nand IGF-1 \\<600ng/ml'}], 'interventions': [{'name': 'Sandostatin (Octreotide Acetate)', 'type': 'DRUG', 'otherNames': ['Sandostatin LAR'], 'description': 'For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone:\n\n* Dose: Sandostatin LAR® 20mg per 4 weeks for 3 months -\\> If serum IFG-1 levels fails to normalize, the dose of LAR will be increased to 30 mg.\n* Frequency: every 4 weeks.\n* Route of administration: IM injection.', 'armGroupLabels': ['Group 2: Surgery + Medical treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'minseon Kim, PhD', 'role': 'CONTACT', 'email': 'mskim@amc.seoul.kr', 'phone': '82-2-3010-3245'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'minseon Kim, PhD', 'role': 'CONTACT', 'email': 'mskim@amc.seoul.kr', 'phone': '82-2-3010-3245'}, {'name': 'heesun Park, college', 'role': 'CONTACT', 'email': 'guccienvy2@naver.com', 'phone': '82-2-3010-4135'}], 'overallOfficials': [{'name': 'minseon Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Korea Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'min seon kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}