Biologic Predictors of Leiomyoma Treatment Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Biologic Predictors of Leiomyoma Treatment Outcomes

Conditions
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Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas

Intervention / Treatment
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* Genetic: DNA analysis
* Other: Hormonal analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give consent Age 18 or older Presence of known uterine leiomyoma Exclusion Criteria: 1. Suspected malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females with uterine fibroids<br>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. | Genetic: DNA analysis<br>* At a future time DNA analysis will be performed<br>Other: Hormonal analysis<br>* Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids. |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine leiomyomas (fibroids or myomas), Uterine fibroids, Fibroids, Uterine leiomyomas