Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-05 @ 12:53 AM
Study NCT ID:
NCT00173251
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'completionDateStruct': {'date': '2006-08'}, 'lastUpdateSubmitDate': '2005-09-12', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'difference in receptor expression level'}]}, 'conditionsModule': {'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'There are more and more macromastic women in Taiwan, which may due to the high cholesterol foods. Patients with macromastia not only suffered from physical problems but also psychological discomforts.', 'detailedDescription': 'Large breasts cause neck and back pain, irritating grooves, cut in the skin of the shoulders by the pressure of brassiere straps, breast pain, and maceration and dermatoses in the inframammary region. From a psychological point of view, excessively large breasts can be troublesome focus of embarrassment for the teenager as well as the woman in her senior years. Unilateral hypertrophy with asymmetry heightens embarrassment. Thus, patients seek to reduce the size of their breasts.\n\nIn the human female, variant receptors were detected in epithelial cells in normal breast tissue, benign breast lesions, breast carcinoma tissue, and breast cancer cell lines2-11. The cause of the difference in breast development status is still unclear. Abnormalities at the tissue receptor level may be important in the pathophysiology of macromastia. This study aimed to make clear the difference in variant receptor levels between breast hypertrophy patients and macromastia ones by examining the receptor levels in breast tissue. Then, we could explore the possible etiology of mammary hypertrophy and macromastia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients receiving reduction mammoplasty\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00173251', 'briefTitle': 'The Difference in Presentation Level of Variant Receptors in Female Breast Tissue in Macromastia and Micromastia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'orgStudyIdInfo': {'id': '9461700605'}}, 'armsInterventionsModule': {'interventions': [{'name': 'obtain surgical specimen for analysis', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hao-Chih Tai, M.D.', 'role': 'CONTACT', 'email': 'phoebe@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5109'}], 'overallOfficials': [{'name': 'Hao-Chih Tai, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}}}}