Biologic Predictors of Leiomyoma Treatment Outcomes
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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 |
- 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
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.
|
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 |
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.
Inclusion Criteria:
- Able and willing to give consent
- Age 18 or older
- Presence of known uterine leiomyoma
Exclusion Criteria:
1. Suspected malignancy
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01936493
| Contact: Lisa G. Peterson,, RN | 507-266-4813 | mayofibroids@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: Elizabeth A. Stewart, M.D. | |
| 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: | November 24, 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 Connective Tissue Diseases Neoplasms |
Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue |
ClinicalTrials.gov processed this record on March 03, 2015