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Clinical Trials/NCT00710346
NCT00710346
Terminated
Not Applicable

Establishment of a Fibroid Tissue Bank

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 site in 1 country43 target enrollmentJune 30, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leiomyoma
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment
43
Locations
1
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2008
End Date
September 1, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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