Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-01-07 @ 1:07 PM
Study NCT ID:
NCT02505256
Status:
UNKNOWN
Last Update Posted:
2015-07-22
First Post:
2015-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Into Treatment of Hyperplasia of Mammary Glands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006965', 'term': 'Hyperplasia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'breast tissues'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-21', 'studyFirstSubmitDate': '2015-07-18', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical manifestations as an substitutive indicator for pathological diagnosis of hyperplasia of mammary glands', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'Clinical manifestations as an surgical indications for hyperplasia of mammary glands', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperplasia']}, 'descriptionModule': {'briefSummary': 'Hyperplasia of Mammary Glands is a complex disease, and there is no consensus or guideline for the treatment of this disease. This study was launched to investigate into the problem that which patients should be diagnosed as hyperplasia of mammary glands and which patients should be treated.', 'detailedDescription': 'Females who meet the inclusion criteria will receive breast ultrasonography, mammography and pathological examinations by core needle biopsy. All participants will receive a follow-up at an 6-month interval for 2 years. During the follow-up period, whether the symptoms relieve will be evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Females who reported breast pain of breast lumps.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Reported breast pain or breast lumps.\n* Willing to be kept follow-up.\n* Functions below are maintained in major organs: liver, renal and heart.\n* Written informed consent will be obtained for patients for entering this study.\n\nExclusion Criteria:\n\n* Typical breast cancer or fibroadenoma.\n* Classification by breast ultrasonography of mammography is beyond Breast Imaging - Reporting And Data System (BI-RADS) 4.\n* Oral contraceptive or hormone replacement therapy.\n* History of breast cancer or other malignancies.\n* History of pituitary gland disease.\n* Potentially pregnant, pregnant, or breast-feeding.'}, 'identificationModule': {'nctId': 'NCT02505256', 'briefTitle': 'Study Into Treatment of Hyperplasia of Mammary Glands', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Study Into Treatment of Hyperplasia of Mammary Glands', 'orgStudyIdInfo': {'id': 'BEST P-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case group', 'description': 'cases who presented as breast pain or breast lumps, and no intervention will be administered.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['case group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250033', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gang Z Yu, Dr; PhD', 'role': 'CONTACT', 'email': 'yzg@medmail.com.cn', 'phone': '+86 0531-85875048'}, {'name': 'Gang Z Yu, Dr; PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'the Second Hospital of Shandong Universtity', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Gang Z Yu, PhD, MD', 'role': 'CONTACT', 'email': 'yzg@medmail.com.cn', 'phone': '+13864182636'}], 'overallOfficials': [{'name': 'Gang Z Yu, PhD，MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Breast Surgery', 'investigatorFullName': 'Yu-Zhi Gang', 'investigatorAffiliation': 'Shandong University'}}}}