Biologic Predictors of Leiomyoma Treatment Outcomes

NCT ID: NCT01936493

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2015-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Leiomyomas Fibroids Uterine Fibroids Myomas

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

DNA analysis

Intervention Type GENETIC

At a future time DNA analysis will be performed

Hormonal analysis

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DNA analysis

At a future time DNA analysis will be performed

Intervention Type GENETIC

Hormonal analysis

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elizabeth A. Stewart

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elizabeth A. Stewart

Professor of Obstetrics-Gynecology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth A. Stewart, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic - Rochester, Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mayoclinic.com/health/uterine-fibroids/DS00078

Mayo Clinic Uterine Fibroids Information

http://on.fb.me/gewuoO

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09-003657

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Personalized Genomic Research
NCT01294345 COMPLETED
Genetic Studies of Lysosomal Storage Disorders
NCT00001215 ENROLLING_BY_INVITATION
Rare and Undiagnosed Disease Research Biorepository
NCT04703179 ENROLLING_BY_INVITATION
Inherited Reproductive Disorders
NCT01500447 RECRUITING