Protocol Number: 08-CH-0170

Title:

Establishment of a Fibroid Tissue Bank

Number:

08-CH-0170

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.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Children

Male

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Leiomyoma

Tissue Repository

Fibroids

Recruitment Keyword(s):

Fibroids

Leiomyoma

Condition(s):

Leiomyoma

Fibroids

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Marshall LM, Spiegelman D, Barbieri RL, Goldman MB, Manson JE, Colditz GA, Willett WC, Hunter DJ. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997 Dec;90(6):967-73.

Lepine LA, Hillis SD, Marchbanks PA, Koonin LM, Morrow B, Kieke BA, Wilcox LS. Hysterectomy surveillance--United States, 1980-1993. MMWR CDC Surveill Summ. 1997 Aug 8;46(4):1-15.

Payson M, Leppert P, Segars J. Epidemiology of myomas. Obstet Gynecol Clin North Am. 2006 Mar;33(1):1-11.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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