Biologic Predictors of Leiomyoma Treatment Outcomes

NCT01936493 | Completed

• 1 other identifier: 09-003657
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Leiomyomas; Fibroids; Uterine Fibroids; Myomas

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.

  baseline

Study Arms (1)

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; Other: Hormonal analysis

Interventions

DNA analysis GENETIC

At a future time DNA analysis will be performed

Females with uterine fibroids

Hormonal analysis OTHER

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

Females with uterine fibroids

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Able and willing to give consent
• Age 18 or older
• Presence of known uterine leiomyoma

You may not qualify if:

• \. Suspected malignancy

Sponsors & Collaborators

• Elizabeth A. Stewart: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

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

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.

MeSH Terms

Conditions

Myofibroma; Leiomyoma; Myoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Elizabeth A. Stewart, M.D.

  Mayo Clinic - Rochester, Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Obstetrics-Gynecology

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: September 6, 2013
• Study Start: August 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 26, 2015
• Last Updated: March 27, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)