Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-03-09 @ 11:35 PM
Study NCT ID:
NCT04096300
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2019-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Integrative Approach for Idiopathic Granulomatous Mastitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biopsy Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Breast Mass Size', 'timeFrame': 'Up to 12 months', 'description': 'Ultrasonic scan at 6 months'}, {'measure': 'Change of Breast Mass Size', 'timeFrame': 'Up to 48 months', 'description': 'Ultrasonic scan at 12 months'}], 'secondaryOutcomes': [{'measure': 'Change of Breast Mass Size', 'timeFrame': 'Up to 48 months', 'description': 'MRI scan at 12 months, if prompted by ultrasonic scan'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Integrative Medicine', 'Ethnomedicine', 'Hirudotherapy', 'Idiopathic Granulomatous Mastitis', 'Medical Cupping Therapy', 'Traditional and Complementary Medicine'], 'conditions': ['Idiopathic Granulomatous Mastitis']}, 'descriptionModule': {'briefSummary': 'Collaboration is established between Turkish Holistic \\& Integrative Medicine Association and Traditional \\& Complementary Medicine Society of Istanbul Medipol University.\n\nStudy is carried out on idiopathic granulomatous mastitis patients who are followed in the Breast Clinic at Istanbul Medipol University Hospital for between September 2015 and September 2019. Hirudotherapy and medical cupping therapy were applied as traditional and complementary medicine integratively.\n\nFollowing initial radiological imaging, microbiological- and histological testing, side effects and relapses are analyzed. Follow-up examination is also carried out at the end of the treatment, which consisted of clinical breast exam and radiological imaging.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving Traditional and Complementary Medicine (T\\&CM) for IGM will be retrospectively analyzed.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IGM patients, either ones newly diagnosed or had previously received different types of treatments, currently refusing conventional treatments with immunosuppressives etc, or/and surgical management, and now und\n\nExclusion Criteria:\n\n* Patients currently using any conventional treatment, and/or contraindication to hirudotherapy and cupping.'}, 'identificationModule': {'nctId': 'NCT04096300', 'acronym': 'IIGM', 'briefTitle': 'An Integrative Approach for Idiopathic Granulomatous Mastitis.', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Traditional and Complementary Medicine: a Cure for Idiopathic Granulomatous Mastitis?', 'orgStudyIdInfo': {'id': 'IMUEC396'}}, 'contactsLocationsModule': {'locations': [{'zip': '34810', 'city': 'Beykoz', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Medipol University', 'geoPoint': {'lat': 41.14389, 'lon': 29.09056}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mujgan Calişkan', 'investigatorAffiliation': 'Medipol University'}}}}