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Establishment of Fibroid Tissue Bank

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
ClinicalTrials.gov Identifier:
NCT00710346
First received: July 3, 2008
Last updated: November 18, 2014
Last verified: November 2014

July 3, 2008
November 18, 2014
June 2008
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Complete list of historical versions of study NCT00710346 on ClinicalTrials.gov Archive Site
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Establishment of Fibroid Tissue Bank
Establishment of a Fibroid Tissue Bank

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.

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.

Observational
Time Perspective: Prospective
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  • Leiomyoma
  • Fibroids
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
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  • INCLUSION CRITERIA:
  • Medically indicated hysterectomy, myomectomy or other surgery for uterine fibroids.
  • Samples from patients with unusual variants of fibroid disease (HLRCC, benign metastasizing leiomyomatosis) will be included. These samples may possibly not arise from the uterus proper, as the leiomyoma may have become located elsewhere in the body.

EXCLUSION CRITERIA:

  • Inability to give consent or understand the consent forms.
  • HIV-infected tissues will be excluded due to concern of equipment contamination.
  • Hepatitis-infected tissues will be excluded due to concern of equipment contamination.
Female
21 Years to 80 Years
No
Contact: James H Segars, M.D. (301) 496-5800 segarsj@mail.nih.gov
United States
 
NCT00710346
080170, 08-CH-0170
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National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: James H Segars, M.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP