Biologic Predictors of Leiomyoma Treatment Outcomes

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.

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Key information

Conditions

Uterine Leiomyomas Connective Tissue Diseases Fibroids Leiomyoma Myofibroma Myoma Myomas Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Skin and Connective Tissue Diseases Uterine Fibroids

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Suspected malignancy

Treatment and study plan

DNA analysis

Genetic

At a future time DNA analysis will be performed

Hormonal analysis

Other

Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.

Primary outcomes

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

Time frame: baseline

Sponsors and collaborators

Lead sponsor

Elizabeth A. Stewart

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Sep 6, 2013
Registry last updated: Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed