Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT01368133
Status:
UNKNOWN
Last Update Posted:
2013-09-26
First Post:
2011-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Observational Study of Growth Hormone-secreting Pituitary Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}, {'id': 'D010911', 'term': 'Pituitary Neoplasms'}], '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'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, DNA and pituitary tumor tissues'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-24', 'studyFirstSubmitDate': '2011-06-06', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acromegaly', 'pituitary tumor'], 'conditions': ['Acromegaly', 'Pituitary Tumor']}, 'descriptionModule': {'briefSummary': 'The major purpose of this study is to evaluate the changes of multiple organs in patients with growth hormone-secreting pituitary tumors before and after surgery. Plasma, DNA samples and pituitary tumor tissues will be kept for further analysis.', 'detailedDescription': 'Multiple organs or systems will be affected by excessive growth hormones in patients with acromegaly. The major purpose of this study is to evaluate the changes before and after the pituitary surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The acromegaly patients at Huashan Hospital will be recruited anf followed up prior to surgery and one month, 3 months, 6 months and 12 months after surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of acromegaly\n* \\> 18 years old'}, 'identificationModule': {'nctId': 'NCT01368133', 'briefTitle': 'The Observational Study of Growth Hormone-secreting Pituitary Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'The Observational Study of the Structures and Functions of Multiple Organs in Patients With Growth Hormone-secreting Tumors', 'orgStudyIdInfo': {'id': '2010M-010'}}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cuiyun Wu', 'role': 'CONTACT', 'email': 'hskyc@fudan.edu.cn', 'phone': '86-21-52888047'}, {'name': 'Zhaoyun Zhang', 'role': 'CONTACT', 'email': 'zhaoyunzhang@fudan.edu.cn', 'phone': '86-21-52888286'}, {'name': 'Yao Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiahui Qiu, M.D.', 'role': 'CONTACT', 'email': 'qiuhuijiaatsjtu@163.com', 'phone': '86-13585951850'}, {'name': 'zhaoyun zhang, M.D.', 'role': 'CONTACT', 'email': 'zhaoyunzhang@fudan.edu.cn', 'phone': '86-21-52888286'}], 'overallOfficials': [{'name': 'Yao Zhao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huashan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zhaoyun Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}