Overview

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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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.
dna analysis
At a future time DNA analysis will be performed
hormonal analysis
Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.

Primary Outcomes

Measure
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
time frame: baseline

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Mayo Clinic.