Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-28 @ 9:04 PM
Study NCT ID:
NCT01936493
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2013-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biologic Predictors of Leiomyoma Treatment Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D009214', 'term': 'Myoma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum aliquots and genomic DNA samples will be collected, processed and stored in the Biospecimen Accessioning Processing (BAP) lab at Mayo Clinic in Rochester, MN.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2013-08-14', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Uterine leiomyomas (fibroids or myomas)', 'Uterine fibroids', 'Fibroids', 'Uterine leiomyomas'], 'conditions': ['Uterine Leiomyomas', 'Fibroids', 'Uterine Fibroids', 'Myomas']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mayoclinic.com/health/uterine-fibroids/DS00078', 'label': 'Mayo Clinic Uterine Fibroids Information'}, {'url': 'http://on.fb.me/gewuoO', 'label': 'Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.', 'detailedDescription': 'There is little information to predict outcomes of leiomyoma therapies. It is clear that both environmental exposures and genetic predisposition influence disease manifestations. Our work has identified a new area of genetic linkage for leiomyomas from a genome wide scan. We therefore propose to prospectively collect biologic samples that will allow us to analyze gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatments using the same methodology used previously. Specifically we will collect serum aliquots, genomic DNA and information using a genetic epidemiology questionnaire. In the short term we will also be able to use prospectively obtained information on epidemiologic and anthropomorphic data to characterize women undergoing treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be enrolled at Mayo Clinic in Rochester, Minnesota. These patients will either be enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to give consent\n2. Age 18 or older\n3. Presence of known uterine leiomyoma\n\nExclusion Criteria:\n\n1\\. Suspected malignancy'}, 'identificationModule': {'nctId': 'NCT01936493', 'briefTitle': 'Biologic Predictors of Leiomyoma Treatment Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Biologic Predictors of Leiomyoma Treatment Outcomes', 'orgStudyIdInfo': {'id': '09-003657'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Females with uterine fibroids', 'description': 'Participants will be females age of 18 or older who have be diagnosed with uterine leiomyoma. Study Subjects will be asked if mothers or siblings also have diagnosis of uterine leoimyoma (either past or present diagnosis) and these family members will be invited to participate in this trial. All participants will provide blood samples for serum aliquots for hormonal analysis and genomic DNA analysis, and will answer a baseline genetic epidemiology questionnaire.', 'interventionNames': ['Genetic: DNA analysis', 'Other: Hormonal analysis']}], 'interventions': [{'name': 'DNA analysis', 'type': 'GENETIC', 'description': 'At a future time DNA analysis will be performed', 'armGroupLabels': ['Females with uterine fibroids']}, {'name': 'Hormonal analysis', 'type': 'OTHER', 'description': 'Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.', 'armGroupLabels': ['Females with uterine fibroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Elizabeth A. Stewart, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic - Rochester, Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth A. Stewart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Obstetrics-Gynecology', 'investigatorFullName': 'Elizabeth A. Stewart', 'investigatorAffiliation': 'Mayo Clinic'}}}}