Biologic Predictors of Leiomyoma Treatment Outcomes

Elizabeth A. Stewart

Status: Completed

Conditions: Fibroids; Uterine Fibroids; Uterine Leiomyomas; Myomas

Treatments: Other: Hormonal analysis; Genetic: DNA analysis

Study type: Observational

Funder types: Other

Identifiers

NCT01936493

09-003657

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Females with uterine fibroids

Description:

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.

Treatment:

Other: Hormonal analysis

Genetic: DNA analysis