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Establishment of a Fibroid Tissue Bank


N/A
21 Years
80 Years
Open (Enrolling)
Female
Leiomyoma, Fibroids

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Trial Information

Establishment of a Fibroid Tissue Bank


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.

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

James H Segars, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

080170

NCT ID:

NCT00710346

Start Date:

June 2008

Completion Date:

Related Keywords:

  • Leiomyoma
  • Fibroids
  • Leiomyoma
  • Tissue Repository
  • Fibroids
  • Leiomyoma
  • Myofibroma

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892