Biologic Predictors of Leiomyoma Treatment Outcomes
This study is ongoing, but not recruiting participants.
Sponsor:
Elizabeth A. Stewart
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01936493
First received: August 14, 2013
Last updated: November 9, 2015
Last verified: November 2015
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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 |
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
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 (Adult, Senior) |
| 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:
- Able and willing to give consent
- Age 18 or older
- Presence of known uterine leiomyoma
Exclusion Criteria:
1. Suspected malignancy
Contacts and Locations
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01936493
Locations
| United States, Minnesota | |
| 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 |
More Information
Additional Information:
| 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 9, 2015 |
| 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 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 September 29, 2016