NCT01936493

Biologic Predictors of Leiomyoma Treatment Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Elizabeth A. Stewart · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Uterine Leiomyomas
• Fibroids
• Uterine Fibroids
• Myomas

Interventions

Type	Name	Description
GENETIC	DNA analysis	At a future time DNA analysis will be performed
OTHER	Hormonal analysis	Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-05-01
• Completion: 2015-05-26
• First posted: 2013-09-06
• Last updated: 2017-03-27

Locations

1 site across 1 country: United States