Biologic Predictors of Leiomyoma Treatment Outcomes

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Uterine Leiomyomas; Fibroids; Uterine Fibroids; Myomas	Genetic: DNA analysis; Other: Hormonal analysis

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 Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	38 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Biologic Predictors of Leiomyoma Treatment Outcomes
Study Start Date :	August 2009
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	May 26, 2015

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort

Intervention/treatment

Females with uterine fibroids; 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.

Genetic: DNA analysis; At a future time DNA analysis will be performed Other: Hormonal analysis; Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids. [ Time Frame: baseline ]

Biospecimen Retention:   Samples With DNA

Serum aliquots and genomic DNA samples will be collected, processed and stored in the Biospecimen Accessioning Processing (BAP) lab at Mayo Clinic in Rochester, MN.

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients will be enrolled at Mayo Clinic in Rochester, Minnesota. These patients will either be enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatment.

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Elizabeth A. Stewart

Investigators

Principal Investigator:	Elizabeth A. Stewart, M.D.	Mayo Clinic - Rochester, Minnesota

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Mayo Clinic Uterine Fibroids Information 

Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids. 

Responsible Party:	Elizabeth A. Stewart, Professor of Obstetrics-Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01936493 History of Changes
Other Study ID Numbers:	09-003657
First Posted:	September 6, 2013
Last Update Posted:	March 27, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Elizabeth A. Stewart, Mayo Clinic:

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

Additional relevant MeSH terms:

Leiomyoma; Myofibroma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases