Biologic Predictors of Leiomyoma Treatment Outcomes
This trial is active, not recruiting.
|Conditions||uterine leiomyomas, fibroids, uterine fibroids, myomas|
|Treatments||dna analysis, hormonal analysis|
|Sponsor||Elizabeth A. Stewart|
|Start date||August 2009|
|End date||December 2016|
|Trial size||120 participants|
|Trial identifier||NCT01936493, 09-003657|
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.
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
time frame: baseline
Female participants at least 18 years old.
Inclusion Criteria: 1. Able and willing to give consent 2. Age 18 or older 3. Presence of known uterine leiomyoma Exclusion Criteria: 1. Suspected malignancy
|Official title||Biologic Predictors of Leiomyoma Treatment Outcomes|
|Principal investigator||Elizabeth A. Stewart, M.D.|
|Description||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.|
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