Uterine FibroidsNCT00339547
Risk Factors for Uterine Fibroids: A Case Control Study
An observational study of Uterine Fibroids, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids
- How many people
- 1,529 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 1995to 23 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All premenopausal women who participated in the initial study are eligible for the current follow-up study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia
About this study
Official title: Risk Factors for Uterine Fibroids: A Case Control Study and Follow-up Amendment to Study Disease Progression
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.
Read more
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, life style factors, and occupational/environmental exposures. Blood will be collected from premenopausal women to measure lipids, insulin, and potential susceptibility genes. Urine will also be collected from premenopausal women early in their menstrual cycles to measure gonadotropin levels. Blood pressure, heart rate, weight, height, and waist-to-hip ration will be measured. Tissue from surgical specimens will be use by collaborators at NIEHS to measure cell proliferation and apoptosis, genetic factors, estrogen and progesterone receptor levels, protein markers of estrogen action, and growth factors.
Read the detailed description
Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Leiomyoma is a common condition with many tumors being asymptomatic. It is not known which women who have fibroids will develop clinical symptoms. In 1996-1999 the NIEHS Uterine Fibroid Study enrolled 1245 randomly selected premenopausal women, aged 35 to 49, who had been randomly selected from the membership roles of George Washington University Health Plan, a large prepaid health plan in Washington, D.C. Slightly over half of the participants were African American. Participants were asked about prior diagnoses of uterine leiomyomas, and 87% were examined by abdominal/transvaginal ultrasound to screen for uterine leiomyoma. Sixty-two percent of the 1245 had either had a prior diagnosis of leiomyoma or had sonogram evidence of the condition.
Study Objectives:
- Monitor fibroid-related symptoms over time (Two follow-ups over a five-year period).
- Measure the proportion of women who undergo major medical intervention (hysteroscopic resection, uterine artery embolization, laser coagulation, myomectomy, or hysterectomy).
- Identify risk factors for increased symptom severity.
- Identify risk factors for treatment intervention.
Methods: Premenopausal participants in the Uterine Fibroid Study (1996-1999) will be recontacted twice during the years 2001 - 2005 to obtain information about leiomyoma-related symptoms and medical or surgical treatments. Data will be collected with a computer-assisted telephone interview. Medical records of ultrasound or MRI examinations and major medical or surgical interventions will be abstracted to verify medical follow-up and treatment.
Significance: The presence of leiomyomas can be identified with ultrasound screening when the condition is asymptomatic. However, no data are available that allow clinicians to predict which women will experience morbidity. This longitudinal study will trace disease progression, and identify factors related to increased symptom severity and medical/surgical treatment. The findings could then be used to develop a systematic scoring system that can be used to identify women at high risk.
- Conditions
- Uterine Fibroids
- Keywords
- Leiomyomas, Ultrasound, Hysterectomy, Epidemiology, Hyperinsulinemia
- Medical subject headings
- Leiomyoma, Hyperinsulinism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Nov 1995
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,529 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Donna D Baird, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339547
- Sponsor's protocol ID
- 999995048
- Other IDs
- OH95-E-N048
- Status last verified
- 23 Jul 2019
- First submitted
- 19 Jun 2006
- Last updated
- 25 Jul 2019
- Results posted
- No
Publications
Lamminen S, Rantala I, Helin H, Rorarius M, Tuimala R. Proliferative activity of human uterine leiomyoma cells as measured by automatic image analysis. Gynecol Obstet Invest. 1992;34(2):111-4. doi: 10.1159/000292738.
PubMed 1356890Cramer SF, Patel A. The frequency of uterine leiomyomas. Am J Clin Pathol. 1990 Oct;94(4):435-8. doi: 10.1093/ajcp/94.4.435.
PubMed 2220671Grover SR, Quinn MA. Is there any value in bimanual pelvic examination as a screening test. Med J Aust. 1995 Apr 17;162(8):408-10.
PubMed 7746172
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Uterine Fibroids: A Case Control Study and Follow-up Amendment to Study Disease Progression
- ClinicalTrials.gov ID
- NCT00339547
- Acronym / sponsor ID
- 999995048
- Conditions
- Uterine Fibroids
- Keywords
- Leiomyomas, Ultrasound, Hysterectomy, Epidemiology, Hyperinsulinemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,529 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 1 Nov 1995
- Study completion
- 23 Jul 2019
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, life style factors, and occupational/environmental exposures. Blood will be collected from premenopausal women to measure lipids, insulin, and potential susceptibility genes. Urine will also be collected from premenopausal women early in their menstrual cycles to measure gonadotropin levels. Blood pressure, heart rate, weight, height, and waist-to-hip ration will be measured. Tissue from surgical specimens will be use by collaborators at NIEHS to measure cell proliferation and apoptosis, genetic factors, estrogen and progesterone receptor levels, protein markers of estrogen action, and growth factors.
Detailed description
Uterine leiomyomas are the leading cause of hysterectomy in the United States, accounting for over 200,000 procedures each year. Leiomyoma is a common condition with many tumors being asymptomatic. It is not known which women who have fibroids will develop clinical symptoms. In 1996-1999 the NIEHS Uterine Fibroid Study enrolled 1245 randomly selected premenopausal women, aged 35 to 49, who had been randomly selected from the membership roles of George Washington University Health Plan, a large prepaid health plan in Washington, D.C. Slightly over half of the participants were African American. Participants were asked about prior diagnoses of uterine leiomyomas, and 87% were examined by abdominal/transvaginal ultrasound to screen for uterine leiomyoma. Sixty-two percent of the 1245 had either had a prior diagnosis of leiomyoma or had sonogram evidence of the condition.
Study Objectives:
- Monitor fibroid-related symptoms over time (Two follow-ups over a five-year period).
- Measure the proportion of women who undergo major medical intervention (hysteroscopic resection, uterine artery embolization, laser coagulation, myomectomy, or hysterectomy).
- Identify risk factors for increased symptom severity.
- Identify risk factors for treatment intervention.
Methods: Premenopausal participants in the Uterine Fibroid Study (1996-1999) will be recontacted twice during the years 2001 - 2005 to obtain information about leiomyoma-related symptoms and medical or surgical treatments. Data will be collected with a computer-assisted telephone interview. Medical records of ultrasound or MRI examinations and major medical or surgical interventions will be abstracted to verify medical follow-up and treatment.
Significance: The presence of leiomyomas can be identified with ultrasound screening when the condition is asymptomatic. However, no data are available that allow clinicians to predict which women will experience morbidity. This longitudinal study will trace disease progression, and identify factors related to increased symptom severity and medical/surgical treatment. The findings could then be used to develop a systematic scoring system that can be used to identify women at high risk.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All premenopausal women who participated in the initial study are eligible for the current follow-up study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Background: PubMed 1356890Lamminen S, Rantala I, Helin H, Rorarius M, Tuimala R. Proliferative activity of human uterine leiomyoma cells as measured by automatic image analysis. Gynecol Obstet Invest. 1992;34(2):111-4. doi: 10.1159/000292738.
- Background: PubMed 2220671Cramer SF, Patel A. The frequency of uterine leiomyomas. Am J Clin Pathol. 1990 Oct;94(4):435-8. doi: 10.1093/ajcp/94.4.435.
- Background: PubMed 7746172Grover SR, Quinn MA. Is there any value in bimanual pelvic examination as a screening test. Med J Aust. 1995 Apr 17;162(8):408-10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna D Baird, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339547, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.