Biologic Predictors of Leiomyoma Treatment Outcomes

Completed

• Conditions: Uterine Leiomyomas; Myomas; Fibroids; Uterine Fibroids
• Interventions: Genetic: DNA analysis; Other: Hormonal analysis

• Registration Number: NCT01936493
• Lead Sponsor: Elizabeth A. Stewart

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-06
• Primary Completion: 2015-05
• Study Completion: 2015-05-26
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Females with uterine fibroids	Hormonal analysis	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.
Females with uterine fibroids	DNA analysis	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.

Primary Outcome Measures

Name	Time	Method
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.	baseline

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States