Uterine LeiomyomasNCT01936493
Biologic Predictors of Leiomyoma Treatment Outcomes
An observational study of Uterine Leiomyomas and Fibroids, run by Elizabeth A. Stewart at 1 site in United States.
Trial summary
The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Leiomyomas, Fibroids, Uterine Fibroids
- What is being tested?
- DNA analysis and Hormonal analysis
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 26 May 2015
- 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 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be enrolled at Mayo Clinic in Rochester, Minnesota. These patients will either be enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatment.
Who may be able to join
- Able and willing to give consent
- Age 18 or older
- Presence of known uterine leiomyoma
Who cannot join
- 1. Suspected malignancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.
Read the detailed description
There is little information to predict outcomes of leiomyoma therapies. It is clear that both environmental exposures and genetic predisposition influence disease manifestations. Our work has identified a new area of genetic linkage for leiomyomas from a genome wide scan. We therefore propose to prospectively collect biologic samples that will allow us to analyze gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatments using the same methodology used previously. Specifically we will collect serum aliquots, genomic DNA and information using a genetic epidemiology questionnaire. In the short term we will also be able to use prospectively obtained information on epidemiologic and anthropomorphic data to characterize women undergoing treatment.
- Conditions
- Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas
- Being tested
- DNA analysis, Hormonal analysis
- Keywords
- Uterine leiomyomas (fibroids or myomas), Uterine fibroids, Fibroids, Uterine leiomyomas
- Medical subject headings
- Myofibroma, Leiomyoma, Myoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
At a future time DNA analysis will be performed
Hormonal analysisOther
Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.
| Study group | Role | What they receive |
|---|---|---|
| Females with uterine fibroids | Participants will be females age of 18 or older who have be diagnosed with uterine leiomyoma. Study Subjects will be asked if mothers or siblings also have diagnosis of uterine leoimyoma (either past or present diagnosis) and these family members will be invited to participate in this trial. All participants will provide blood samples for serum aliquots for hormonal analysis and genomic DNA analysis, and will answer a baseline genetic epidemiology questionnaire. Receives: Genetic: DNA analysis; Other: Hormonal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startAug 2009
- Primary completionMay 2015
- Study completion26 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomasStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth A. Stewart
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth A. Stewart, Mayo Clinic
- Investigators
- Elizabeth A. Stewart, M.D., Principal investigator, Mayo Clinic - Rochester, Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936493
- Sponsor's protocol ID
- 09-003657
- Status last verified
- Mar 2017
- First submitted
- 14 Aug 2013
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Predictors of Leiomyoma Treatment Outcomes
- ClinicalTrials.gov ID
- NCT01936493
- Acronym / sponsor ID
- 09-003657
- Conditions
- Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas
- Keywords
- Uterine leiomyomas (fibroids or myomas), Uterine fibroids, Fibroids, Uterine leiomyomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Elizabeth A. StewartUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2015 (actual)
- Study completion
- 26 May 2015 (actual)
- First posted
- 6 Sep 2013 (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 purpose of this study is to search for the hereditary (genetic) causes of uterine fibroids. Some women with uterine fibroids may have one or more genes that make them more likely to develop uterine fibroids. We are trying to identify these genes to better understand how and why uterine fibroids develop and to design better treatment options for women with uterine fibroids. This information may also help us to understand and treat other problems that may be caused by these genes.
Detailed description
There is little information to predict outcomes of leiomyoma therapies. It is clear that both environmental exposures and genetic predisposition influence disease manifestations. Our work has identified a new area of genetic linkage for leiomyomas from a genome wide scan. We therefore propose to prospectively collect biologic samples that will allow us to analyze gene/environment interactions of women enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatments using the same methodology used previously. Specifically we will collect serum aliquots, genomic DNA and information using a genetic epidemiology questionnaire. In the short term we will also be able to use prospectively obtained information on epidemiologic and anthropomorphic data to characterize women undergoing treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Females with uterine fibroids | – | Genetic: DNA analysis, Other: Hormonal analysisParticipants will be females age of 18 or older who have be diagnosed with uterine leiomyoma. Study Subjects will be asked if mothers or siblings also have diagnosis of uterine leoimyoma (either past or present diagnosis) and these family members will be invited to participate in this trial. All participants will provide blood samples for serum aliquots for hormonal analysis and genomic DNA analysis, and will answer a baseline genetic epidemiology questionnaire. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled at Mayo Clinic in Rochester, Minnesota. These patients will either be enrolled in leiomyoma clinical trials or undergoing leiomyoma clinical treatment.
Key inclusion criteria (3 listed)
- Able and willing to give consent
- Age 18 or older
- Presence of known uterine leiomyoma
Key exclusion criteria (1 listed)
- 1. Suspected malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA analysisAt a future time DNA analysis will be performed | Genetic | Females with uterine fibroids |
| Hormonal analysisParticipants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed. | Other | Females with uterine fibroids |
Primary outcome
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids.
Time frame: baseline
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 27 Mar 2017.
- Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Elizabeth A. Stewart, M.D. principal investigator
Mayo Clinic - Rochester, Minnesota
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 Leiomyomas and Fibroids, run by Elizabeth A. Stewart 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 3 inclusion and 1 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 27 Mar 2017. 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.
What does the primary outcome measure?
Analyze environmental exposures and genetic predisposition among women exhibiting disease manifestations of uterine fibroids. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.