Biologic Predictors of Leiomyoma Treatment Outcomes
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ClinicalTrials.gov Identifier: NCT01936493 |
Recruitment Status
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Completed
First Posted
: September 6, 2013
Last Update Posted
: March 27, 2017
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Condition or disease | Intervention/treatment |
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Uterine Leiomyomas Fibroids Uterine Fibroids Myomas | Genetic: DNA analysis Other: Hormonal analysis |
Study Type : | Observational |
Actual Enrollment : | 38 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Biologic Predictors of Leiomyoma Treatment Outcomes |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | May 2015 |
Actual Study Completion Date : | May 26, 2015 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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- Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids. [ Time Frame: baseline ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Able and willing to give consent
- Age 18 or older
- Presence of known uterine leiomyoma
Exclusion Criteria:
1. Suspected malignancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936493
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Elizabeth A. Stewart, M.D. | Mayo Clinic - Rochester, Minnesota |
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 |
First Posted: | September 6, 2013 Key Record Dates |
Last Update Posted: | March 27, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Elizabeth A. Stewart, 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 |