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NCT00340288 · ClinicalTrials.gov registry record
Fibroid Growth Study
A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Completed
- Registry status
- 123
- Enrollment target
NCT00340288: Completed study, sponsored by National Institute of Environmental Health Sciences (NIEHS).
NCT00340288 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 123 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00340288 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- COMPLETED
- Registry status
- 123 participants
- Enrollment target
Study Summary
Uterine leiomyomas, commonly called fibroids, are a major health concern for women of reproductive age. The objectives of the study described herein are to investigate the growth dynamics of uterine leiomyomas in a clinically relevant population of women. We will test the hypotheses that uterine leiomyomas are heterogeneous in terms of their growth characteristics and in their clinical symptoms or outcomes, and that differences in leiomyoma growth dynamics can be discriminated by molecular markers and cellular phenotypes. Participants will include 300 premenopausal women (greater than 18 years old) with at least one uterine leiomyoma. The inclusion criteria for patient enrollment is confirmed diagnosis of leiomyoma by ultrasound. At least one leiomyoma must be equal to or greater than 2 cm in diameter and the uterus must be enlarged to the size typical during the eigth week of pregnancy. After enrollment and informed consent, T1- and T2-weighted magnetic resonance image (MRI) scans will be conducted beginning at the first visit and then at 3, 6, and 12 months. Each patient will have a physical exam, provide urine and blood samples at each MRI visit, and respond to an initial extensive telephone-administered questionnaire followed by abbreviated monthly questionnaire updates. A number of the enrolled women will require surgical intervention (hysterectomy/myomectomy) as standard care. If surgery is an outcome for women enrolled in the study, MRI will be conducted before surgery and the surgical pathologist will map uterine leiomyomas for comparison to MRI. Leiomyoma samples will be analyzed for histopathological and molecular changes correlated with growth. Because hysterectomy and myomectomy are common outcomes in women with leiomyomas, we anticipate tissue will be available from at least 100 of the 300 women in the study. For those women who opt for surgery, we will also administer a brief (less than 5 minute) questionnaire clarifying their reason for electing surge
Primary Outcome
leiomyoma growth dynamics
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2001-06-27 |
| Est. Completion | 2019-12-18 |
What the finished NCT00340288 record still lists
NCT00340288 is an observational study that tracks outcomes without assigning an intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00340288 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00340288 about?
NCT00340288 is a clinical study titled "Fibroid Growth Study". Uterine leiomyomas, commonly called fibroids, are a major health concern for women of reproductive age. The objectives of the study described herein are to investigate the growth dynamics of uterine leiomyomas in a clinically relevant population of women. We will test the hypotheses that uterine lei...
What is the current status of trial NCT00340288?
This trial is currently completed. The enrollment target is 123 participants. The study started on 2001-06-27. Estimated completion is 2019-12-18.
Who is sponsoring clinical trial NCT00340288?
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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