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Clinical Trials/NCT01936493
NCT01936493
Completed
Not Applicable

Biologic Predictors of Leiomyoma Treatment Outcomes

Elizabeth A. Stewart1 site in 1 country38 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uterine Leiomyomas
Sponsor
Elizabeth A. Stewart
Enrollment
38
Locations
1
Primary Endpoint
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
May 26, 2015
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Elizabeth A. Stewart
Responsible Party
Sponsor Investigator
Principal Investigator

Elizabeth A. Stewart

Professor of Obstetrics-Gynecology

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Able and willing to give consent
  • Age 18 or older
  • Presence of known uterine leiomyoma

Exclusion Criteria

  • Suspected malignancy

Outcomes

Primary Outcomes

Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.

Time Frame: baseline

Study Sites (1)

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