|Registry at a Glance|  |Background|  |Organizational Structure|  |Research Objectives| |Site Expectations and Benefits| |Timeline| |Projected Enrollment|  |Registry Steering Committee|  |Acknowledgements|

The Cardiovascular and Interventional Radiology Research and Education Foundation (CIRREF) and the Society of Interventional Radiology (SIR), in cooperation with the Duke Clinical Research Institute (DCRI), have established the Uterine Artery Embolization (UAE) Fibroid Registry for Outcomes Data (FIBROID). The registry brings together a tremendous depth of scientific and technical resources through the collaborative efforts and support of a professional medical society, academic research organization, the U.S. Food and Drug Administration (FDA), industry and consumers.

The purpose of the FIBROID Registry is to assess the procedure's durability, impact on fertility and quality-of-life, and to obtain data which will allow researchers to compare UAE to other fibroid therapies. This goal will be achieved by capturing a concise set of baseline, short and long term functional and clinical outcome data for patients undergoing UAE. Secondary objectives of this study include: measuring the number of patients undergoing UAE; assessing and benchmarking clinical practice patterns (patient selection, technique, use of procedure across country); and collecting and quantifying resource utilization of patients undergoing UAE.

The registry is open to all SIR members performing UAE who have Internet access. It is estimated that the registry will collect baseline data on approximately 2500 patients per year with longitudinal follow-up on 900 patients per year. Consecutive patients undergoing UAE for uterine fibroids at participating sites will be approached by the treating interventional radiologist for consent for inclusion into the registry. Patient characteristics, procedural data, in-hospital events, and post-discharge events (to 30 days) will be collected on all patients. Data will be entered by site personnel onto web-based data forms and submitted to the registry blinded as to patient identifying information.

In order to maximize resources, longitudinal data greater than 30 days will be collected from approximately 25 core sites. Patients from the core sites will be selected for follow-up. These participants will receive a follow-up survey at 6 months, 12 months, and 24 months following the procedure for assessment of clinical outcomes, quality-of-life (QOL) and patient satisfaction. Surveys will be mailed by DCRI, the data-coordinating and analyses center, directly to the patient. Patients who do not return surveys will be contacted by phone to obtain the follow-up information. In addition, all consented patients intending subsequent pregnancy will be assessed for fertility and pregnancy history during these periodic contacts.

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Registry at a Glance

Background

Since UAE for the treatment of fibroids was first introduced in the United States five years ago, there has been exponential growth. During 2000 alone, over 4500 procedures were performed in this country, which is greater than the aggregate experience of the first four years. According to a survey conducted by SIR in October 2000, approximately 10,500 procedures have been documented worldwide. It is also worth noting the rapid diffusion of this procedure from academic to non-academic settings as well as geographically, as UAE is currently being performed in 47 states and the District of Columbia. UAE offers great promise for patient care as a safer, less invasive treatment for fibroids.

In June 1999, in recognition of the research needed to advance UAE, CIRREF funded RAND Health to convene a multi-disciplinary panel to develop a consensus around a research strategy. The results of this panel, Uterine Artery Embolization: A Systematic Review of the Literature and Proposal for Research identified four areas of research including the development of a disease-specific quality-of-life (QOL) instrument, a randomized control trial, a prospective registry, and a cost analysis. CIRREF funded a grant to design, test and validate a QOL instrument that will be used in the registry to assess changes in patients’ quality-of-life.

The data generated by the registry database, used in conjunction with data from randomized studies, will evaluate the use, safety and effectiveness of UAE for leiomyomata and will assess the potential advantages and disadvantages of the procedure (e.g., durability, fertility, surgical conversions, etc.). It will also be used to facilitate long-term surveillance of patients undergoing this procedure. In addition, the registry may be used as a Continuous Quality Improvement (CQI) tool on behalf of practicing interventional radiologists and will contribute to the development and refinement of standards of care.

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Organizational Structure

CIRREF and SIR are providing the necessary oversight and leadership to ensure the successful development and implementation of the registry.

The Registry Steering Committee, chaired by SIR Past President, Matthew Mauro, MD, is responsible for defining and prioritizing the objectives and goals of the registry and providing input into the project processes, as well as overseeing access to and publication of registry data

The Duke Clinical Research Institute (DCRI), the data-coordinating center and analysis center, will have the primary responsibility for study design, including data collection, analysis and reporting. DCRI will work with the sites to ensure IRB approval and quality assurance issues at the site level. DCRI has a long history and excellent reputation in the design and conduct of clinical trials, registries, and outcome studies.

Sites are a key component of the registry, as they will be contributing all data. Only through the active participation of the sites will the registry be able to meet its goals. All SIR and CIRSE members performing UAE are encouraged to contribute data to the registry as participating sites. All sites will designate an individual to participate as a Lead Investigator, who will be responsible for timely and accurate data contribution. Please see Site Benefits and Expectations (Word, 22k) for more information.

Approximately twenty-five high-volume sites have been identified to participate in the registry as core sites. A random sample of patients from these sites will be followed longitudinally. Core sites have additional requirements for baseline data and are required to complete all of the data elements on the case report form. As such, the core sites will be required to provide greater resources (e.g., provision of study coordinator, travel to meetings) to support the registry than other sites.

An Industry Advisory Committee, comprised of representatives from the industry sponsors, will provide guidance to the Registry Steering Committee as well as input into the design of the registry and analyses. The industry sponsors of the registry are Boston Scientific MEDI-TECH, Cordis, a Johnson & Johnson Company, Biosphere Medical and Cook Diagnostic and Radiology. Please visit their Web sites to learn more about their products.

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Research Objectives

Research Questions:

• Is UAE a safe treatment for leiomyomata? What is the incidence of minor and serious short-term complications?

• Is UAE an effective treatment for leiomyomata? What is the likelihood of symptom relief?

• How durable is the treatment? What is the likelihood of a subsequent procedure or medical therapy to treat recurrent symptoms of leiomyomata?

• What is the likelihood that a woman who undergoes UAE and plans subsequent pregnancy will be able to conceive and deliver a subsequent intrauterine pregnancy?

• Is there a difference in outcome based on device (product size, primary and secondary embolic material) used?

• Are there certain patient subgroups at higher risk or that have an increased likelihood of treatment benefits?

• What number of procedures should be recommended for training and to maintain skills?

Registry Goals:

• To capture high quality patient safety and effectiveness data for UAE.

• To demonstrate patient volume as well as acute outcome event rates for patients undergoing UAE.

• To collect and quantitate longitudinal functional and clinical outcomes of patients undergoing UAE.

• To assess and benchmark clinical practice patterns (patient selection, devices, use of procedure across country).

• To facilitate data collection for post-marketing surveillance and randomized clinical trials (using infrastructure in place for the registry).

• To collect and quantitate resource utilization of patients undergoing UAE.

• To develop and refine standards of care for use of UAE for leiomyomata.

• To monitor risk-adjusted procedural outcomes.

• To provide data to support development and design of randomized clinical trials.

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Site Expectations and Benefits

Benefits

• Play a key role in validating UAE as an effective treatment for fibroids and its acceptance by third party payers and others.

• Access to pooled registry data for analysis or publication.

• Data reports on your patient population undergoing UAE and acute outcomes.

• Reports of national clinical practice patterns and benchmarks.

• Recognition on the CIRREF FIBROID Registry Web site and in the UFE Physician Locator.

• Access to Duke Clinical Research Institute (DCRI), the data coordinating center, expertise in data collection and analysis.

• Centralized longitudinal patient follow-up at core sites through DCRI.

• Permission to use designation as participating or core site in marketing activities.

Site Expectations

• Achieve IRB approval

• Obtain informed consent on all patients entered into the registry

• Attempt to enroll all patients into study

• Complete required fields on case report form (CRF) for each patient in a timely fashion and enter data into web-based interface

• Have stable Internet access

• Identify site principal investigator

• Adhere to SIR Training Standards

• Maintain regulatory documents in accordance with Good Clinical Practice Guidelines

Core Site Expectations

In addition to the above requirements, core sites will also be expected to:

• Complete all data elements of case report form and additional baseline requirements in a timely manner

• Provide study coordinator

• Be open to using approved agents/devices

• Be able to achieve IRB approval within 2 months

• Attend a one-day mandatory training session with study coordinator

• Travel to attend lead investigator meetings that will be held in conjunction with regularly scheduled meetings (e.g., SIR, RSNA). Core sites will be responsible for their own travel to attend these trainings and meetings

• Participate in other meetings or training as needed (meetings, conference calls, etc.)

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Timeline

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Acknowledgements

CIRREF gratefully acknowledges the support of the FIBROID Registry through unrestricted grants provided by Boston Scientific/MEDI-TECH, Cordis, a Johnson & Johnson company, Biosphere Medical and Cook Diagnostic and Radiology.

CIRREF also acknowledges those individuals who have privately donated funds and thanks them for helping to advance this important research. If you are interested in helping to support the FIBROID Registry, please contact the CIRREF office at (800) 488-7284.

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