Uterine FibroidsNCT02819609
Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
An observational study of Uterine Fibroids, run by Quintiles, Inc..
Trial summary
The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect… Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- myomectomy, endometrial ablation and uterine artery embolization
- Type of treatment
- Surgery or procedure
- How many people
- 12,234 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jan 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 54 years
- Women only
- No healthy volunteers
- Adult
Study population: The patient population for the retrospective data analysis was uterine fibroid patients who have a record of at least 1 of the procedures of interest occurring during the time period of January 1, 2005 - December 31, 2011, with the first instance being designated as the index date. The study time period spanned from January 1, 2004 - December 31, 2013 to allow for 12 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of 2 years follow-up.
Who may be able to join
- Female patients with a diagnosis of uterine fibroids at any time and at least 1 office visit during study time period
- At least 1 of the procedures of interest occurring between January 1, 2005 - December 31, 2011
- ≥ 18 years and < 55 years of age at the index date
Who cannot join
- Patients with a diagnosis of gynecologic cancer (ovarian, uterine, cervical)
- First recorded diagnosis of uterine fibroids occurring beyond four weeks after the Index Date ONLY for patients who underwent endometrial ablation or hysterectomy
- Patients with a record of any procedures of interest occurring before January 1, 2005
About this study
The purpose of this observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.
- Conditions
- Uterine Fibroids
- Being tested
- myomectomy, endometrial ablation, uterine artery embolization, MRI-guided focused ultrasound ablation
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myomectomyProcedure or surgery
Myomectomy as part of routine clinical care
endometrial ablationProcedure or surgery
Endometrial ablation as part of routine clinical care
uterine artery embolizationProcedure or surgery
Uterine artery embolization as part of routine clinical care
MRI-guided focused ultrasound ablationProcedure or surgery
MRI-guided focused ultrasound ablation as part of routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| Myomectomy | Women with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care Receives: Procedure: myomectomy | |
| Endometrial ablation | Women with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care Receives: Procedure: endometrial ablation | |
| Uterine artery embolization | Women with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care Receives: Procedure: uterine artery embolization | |
| MRI-guided focused ultrasound ablation | Women with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care Receives: Procedure: MRI-guided focused ultrasound ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Measured: Minimum of two years after index procedure
Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Measured: Minimum of two years after index procedure
Number of uterine fibroids patients who experience a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Measured: Minimum of two years after index procedure
Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Measured: Minimum of two years
Effect of stakeholder participation in the research process
Measured: From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quintiles, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Medical Technology Policy, Duke University
- Responsible party
- Principal investigator, Priscilla Velentgas, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819609
- Sponsor's protocol ID
- CE-12-11-4430
- Status last verified
- Jun 2016
- First submitted
- 12 Feb 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
- ClinicalTrials.gov ID
- NCT02819609
- Acronym / sponsor ID
- CE-12-11-4430
- Conditions
- Uterine Fibroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,234 participants (actual)
- Lead sponsor
- Quintiles, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Center for Medical Technology Policy, Duke University
- Study start
- Nov 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Jun 2016 (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 observational, retrospective database study of patients with uterine fibroids is to compare the durability of symptom relief after uterus-conserving treatments for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and subsequent procedures and evaluate the effect stakeholder participation had on the research process.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Myomectomy | – | Procedure: myomectomyWomen with uterine fibroids who underwent myomectomy as their index procedure as part of their routine clinical care |
| Endometrial ablation | – | Procedure: endometrial ablationWomen with uterine fibroids who underwent endometrial ablation as their index procedure as part of their routine clinical care |
| Uterine artery embolization | – | Procedure: uterine artery embolizationWomen with uterine fibroids who underwent uterine artery embolization as their index procedure as part of their routine clinical care |
| MRI-guided focused ultrasound ablation | – | Procedure: MRI-guided focused ultrasound ablationWomen with uterine fibroids who underwent MRI-guided focused ultrasound ablation as their index procedure as part of their routine clinical care |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patient population for the retrospective data analysis was uterine fibroid patients who have a record of at least 1 of the procedures of interest occurring during the time period of January 1, 2005 - December 31, 2011, with the first instance being designated as the index date. The study time period spanned from January 1, 2004 - December 31, 2013 to allow for 12 months pre-index for evaluating baseline demographic and clinical characteristics and 24 months post-index, ensuring a minimum of 2 years follow-up.
Key inclusion criteria (3 listed)
- Female patients with a diagnosis of uterine fibroids at any time and at least 1 office visit during study time period
- At least 1 of the procedures of interest occurring between January 1, 2005 - December 31, 2011
- ≥ 18 years and < 55 years of age at the index date
Key exclusion criteria (3 listed)
- Patients with a diagnosis of gynecologic cancer (ovarian, uterine, cervical)
- First recorded diagnosis of uterine fibroids occurring beyond four weeks after the Index Date ONLY for patients who underwent endometrial ablation or hysterectomy
- Patients with a record of any procedures of interest occurring before January 1, 2005
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 |
|---|---|---|
| myomectomyMyomectomy as part of routine clinical care | Procedure or surgery | Myomectomy |
| endometrial ablationEndometrial ablation as part of routine clinical care | Procedure or surgery | Endometrial ablation |
| uterine artery embolizationUterine artery embolization as part of routine clinical care | Procedure or surgery | Uterine artery embolization |
| MRI-guided focused ultrasound ablationMRI-guided focused ultrasound ablation as part of routine clinical care | Procedure or surgery | MRI-guided focused ultrasound ablation |
Primary outcome
Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Time frame: Minimum of two years after index procedure
Time to new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Time frame: Minimum of two years after index procedure
Number of uterine fibroids patients who experience a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Time frame: Minimum of two years after index procedure
Time to a subsequent procedure after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation)
Time frame: Minimum of two years
Effect of stakeholder participation in the research process
Time frame: From first stakeholder conference (April 2014) to final stakeholder conference (November 2015)
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 30 Jun 2016.
Related trials for Uterine Fibroids
Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Fibroids, run by Quintiles, Inc..
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 3 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of uterine fibroids patients who experience new or recurrent symptoms after uterus-conserving treatments (myomectomy, endometrial ablation, uterine artery embolization, magnetic resonance imaging [MRI]-guided focused ultrasound ablation) (time frame: Minimum of two years after index procedure). The study lists 5 primary outcomes in all. 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 30 Jun 2016.