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Biologic Predictors of Leiomyoma Treatment Outcomes

Biologic Predictors of Leiomyoma Treatment Outcomes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01936493
Enrollment
38
Registered
2013-09-06
Start date
2009-08-31
Completion date
2015-05-26
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroids, Myomas, Uterine Fibroids, Uterine Leiomyomas

Keywords

Uterine leiomyomas (fibroids or myomas), Uterine fibroids, Fibroids, Uterine leiomyomas

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.

Interventions

GENETICDNA analysis

At a future time DNA analysis will be performed

OTHERHormonal analysis

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

Sponsors

Elizabeth A. Stewart
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026