Establishment of Fibroid Tissue Bank
| Status: | Terminated |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 6/3/2018 |
| Start Date: | June 30, 2008 |
| End Date: | September 1, 2016 |
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.
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.
(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:
- Women aged 21-80 with uterine fibroids
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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