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NCT00339547 · ClinicalTrials.gov registry record
Risk Factors for Uterine Fibroids: A Case Control Study
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 1,529
- Enrollment target
NCT00339547: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00339547 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 1,529 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00339547 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 1,529 participants
- Enrollment target
Study Summary
The proposed study is designed to estimate the proportion of 35-49 year-old women in a large urban health plan who have had fibroids. The membership of the health plan is approximately 45% black, so estimates for black and white women can be compared. Risk factors for the condition will be studied, and uterine tissue from women having hysterectomies or myomectomies will be studied to identify genetic, hormonal, and protein mediators of tumor growth. A randomly selected sample of about 1800 women age 35-49 who are members of the George Washington University Health Plan will be invited to participate. Presence of leiomyomas for premenopausal participants with no prior diagnosis of leiomyoma will be determined by an ultrasound examination. Presence of leiomyomas for premenopausal women who report a prior diagnosis of fibroids will be determined by ultrasound evidence in their medical record when available, and by self-report when not available. History of fibroids in postmenopausal women will be based on pathology records for those with surgical menopause and on radiology records or self-report for the small number of naturally postmenopausal women. Estimates of the proportion who have or have had fibroids will be compared for blacks and whites. To examine risk factors for leiomyoma we will conduct a case-control analysis. Cases will be those women identified with leiomyoma from the random sample, supplemented by women in the same age range who have hysterectomies or myomectomies during the study period and hose excised uteri show evidence of fibroids on standard pathology examination. Women from the random sample with ultrasound or pathology evidence showing no uterine fibroids will constitute the control group. Controls will be compared to cases grouped by size of largest fibroid and grouped by clinical. A telephone interview and self-administered questionnaire will provide information on demographic factors, medical history, dietary intake, reproductive history,
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,529 participants |
| Start Date | 1995-11-01 |
| Est. Completion | 2019-07-23 |
What the finished NCT00339547 record still lists
NCT00339547 is an observational study that tracks outcomes without assigning an intervention. Its 1,529 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00339547 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00339547 about?
NCT00339547 is a clinical study titled "Risk Factors for Uterine Fibroids: A Case Control Study". The proposed study is designed to estimate the proportion of 35-49 year-old women in a large urban health plan who have had fibroids. The membership of the health plan is approximately 45% black, so estimates for black and white women can be compared. Risk factors for the condition will be studied, ...
What is the current status of trial NCT00339547?
This trial is currently completed. The enrollment target is 1,529 participants. The study started on 1995-11-01. Estimated completion is 2019-07-23.
Who is sponsoring clinical trial NCT00339547?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
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