Establishment of Fibroid Tissue Bank
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|ClinicalTrials.gov Identifier: NCT00710346|
Recruitment Status : Terminated
First Posted : July 4, 2008
Last Update Posted : June 1, 2018
The purpose of this study is to collect information and tissue samples from women with uterine fibroids. The samples will be used to study genes, proteins and other substances in order to better understand the disease process and improve fertility and reproductive health.
Women who are scheduled to undergo hysterectomy, myomectomy or other surgery due to uterine fibroids or to an unusual variant of fibroid disease, such as HLRCC or benign metastasizing leiomyomatosis, may be eligible for this study.
Tissue samples are collected from participants during surgery. The samples are coded and catalogued for research use. Data collected regarding the surgery include the sample location, surgery type, reason for surgery and the primary and secondary diagnoses. Additional data collected about the participant include date of birth, race, ethnicity, weight, height, smoking status, information about menstrual cycles, medications and family history.
|Condition or disease|
The long term goal of this protocol is to create a repository of well-characterized fibroid (leiomyoma) tissues in order to gather information that will lead to improved understanding of uterine fibroid growth and pathogenesis. It is expected that this initiative will eventually improve fertility and reproductive health of the millions of women who suffer from fibroids.
To address the need for increased research in this field, the NICHD in collaboration with the Office of Research on Women s Health (ORWH) will establish a national fibroid tissue bank. This initiative will strengthen the science base, improve our understanding of how uterine fibroids develop and grow, and provide clues to more effective conservative management of fibroids. The rationale for this protocol is that a repository of well-characterized, well-preserved leiomyoma tissues will provide investigators interested in basic and translational research on fibroids the opportunity to study the condition. This will facilitate research because experiments conducted on the samples may be expected to improve understanding of the mechanism and pathophysiology of this disease.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Establishment of a Fibroid Tissue Bank|
|Study Start Date :||June 30, 2008|
|Study Completion Date :||September 1, 2016|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710346
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Alan H DeCherney, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|