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Biologic Predictors of Leiomyoma Treatment Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01936493
First received: August 14, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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 Intervention
Uterine Leiomyomas
Fibroids
Uterine Fibroids
Myomas
Genetic: DNA analysis
Other: Hormonal analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biologic Predictors of Leiomyoma Treatment Outcomes

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids. [ Time Frame: baseline ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01936493

Contacts
Contact: Lisa G. Peterson,, RN 507-266-4813 mayofibroids@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Elizabeth A. Stewart, M.D.         
Sponsors and Collaborators
Elizabeth A. Stewart
Investigators
Principal Investigator: Elizabeth A. Stewart, M.D. Mayo Clinic, Rochester, Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Elizabeth A. Stewart, Professor of Obstetrics-Gynecology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01936493     History of Changes
Other Study ID Numbers: 09-003657
Study First Received: August 14, 2013
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Uterine leiomyomas (fibroids or myomas)
Uterine fibroids
Fibroids
Uterine leiomyomas

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Myoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 19, 2014