Biologic Predictors of Leiomyoma Treatment Outcomes

• Sponsor: Elizabeth A. Stewart (Other)
• Overall Status: Completed
• CT.gov ID: NCT01936493
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Duration (Months): 69.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
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

• 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: Aug 1, 2009
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 26, 2015

Arms and Interventions

Arm

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Elizabeth A. Stewart, Professor of Obstetrics-Gynecology, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01936493
• Other Study ID Numbers: 09-003657
• First Posted: Sep 6, 2013
• Last Update Posted: Mar 27, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Elizabeth A. Stewart, Professor of Obstetrics-Gynecology, Mayo Clinic: Uterine leiomyomas (fibroids or myomas); Uterine fibroids; Fibroids; Uterine leiomyomas
• Additional relevant MeSH terms: Leiomyoma; Myofibroma

Study Results

No Results Posted as of Mar 27, 2017