Join the circle. Break the cycle.

Title: Uterine Cancer Registry
Principal Investigator: G. Larry Maxwell, MD
Site: Uterine Cancer Registry at the Gynecologic Cancer Center of Excellence (GYN-COE),
3289 Woodburn Road, Suites 370 and 390, Annandale, VA 22003.
Website: https://www.endgyncancer.com
Email: ucr@endgyncancer.com
Phone: (703) 785-3250
Fax: (703) 852-4348

This is a web-based Registry focused on Uterine Cancer. The Registry is a research study for women with a history of uterine cancer, including endometrial cancer, to join and provide information to support research. Participation in the Registry is completely voluntary and will not influence your medical care. You are free to decide what you want to contribute to the Registry for research. Also, you will be able to change any of your decisions regarding research or withdraw from the Registry at any time. Your decision will not result in any penalty or loss of benefits to which you are entitled.

Because this is a research study, each woman who joins the Registry will need to complete an online consent process. This can be done by reading or listening to an audio clip for this consent document, viewing a consent video, and electronically signing this consent. Because this is a web-based Registry, these steps are all performed online. Select the Schedule an Appointment link to talk with a Registry Technician if you have questions about the Registry. Thank you for taking the time to learn about the Uterine Cancer Registry. Please let us know if you are interested in joining the circle to break the cycle. Working together we hope to pay it forward and put an end to GYN cancer.

1. PURPOSE OF THE STUDY

This Registry is being established to support high quality research and make rapid advances that benefit women who develop uterine cancer. Women with a history of uterine cancer are eligible to join the Registry and contribute data to support research. Research performed using data from patients with the disease or condition of interest are the most likely to yield clinically meaningful results. We anticipate that up to 20,000 women will enroll in this Registry.

For the last four decades, the number of women who are diagnosed with and die from this disease has continued to rise. Data from women with uterine cancer are needed to support research studies with the following ultimate goals:

• Improve patient care, early detection, survivorship, personalized medicine, cancer prevention and outcomes
• Eliminate barriers to access and care as well as disparities in outcomes
• Include patient preferences into clinical treatments and management decisions

As data are used to support research, results will be published and used to support additional research studies. As knowledge and advances in science, medicine and technology continue to evolve, the Registry will continue to make advances that benefit patients and society.

2. WHY ARE YOU BEING ASKED TO PARTICIPATE IN THE STUDY?

You are being asked to join the Registry if you have a history of uterine cancer, are at least 18 years old, and are able to make your own decisions.

3. WHAT ARE THE BENEFITS TO TAKING PART IN THIS STUDY?

You are not likely to directly benefit from contributing data to the Registry to support research. We hope this study will benefit women in the future.

4. WHAT ARE YOU BEING ASKED TO DO AND CONTRIBUTE?

If you consent to being a part of the Uterine Cancer Registry, you will become a Member of the Registry. You will create an account and be given opportunities to contribute data and medical reports about you and your cancer to support research. You decide what you do and do not want to contribute for research. You also decide whether you want to be contacted about other research opportunities for which you may qualify. These other studies are optional and voluntary and may include special Registry sub-studies or independent companion research studies.

Registration Includes the Following Activities:

• Attest: You will be asked to attest (confirm) that: (1) You understand that participation in the Registry is voluntary and will not change your medical care. (2) You are free to decide what you contribute to the Registry for research. (3) You can change your consent choices and/or withdraw from the Registry at any time.
• Options: You will be asked to answer two questions within this consent confirming (1) whether or not you are willing to contribute data for research, and (2) whether or not you agree to be contacted about other research opportunities for which you may qualify.
• Electronic Signature:To complete the consent process, you will be asked to type your name and the date, electronically sign the online consent, and click the submit button.
• Member Account: You will then be asked to create a Member account for the Registry and provide an email address, a username and a password. If you do not have an email address and want one, you will be able to select the GMAIL icon displayed on the section to create a free email account. To enable the Registry to reset your username or password, you must select two security questions from a list and provide answers to these questions. Your user account details, including your security questions and answers, will become part of your personal Member Profile.
• Member Login:Your username and password will allow you to login to the private Members website of the Uterine Cancer Registry.
• Consent Access: An electronic copy of the signed and dated consent will appear on the Welcome Screen for New Members of the Registry the first time you login. The consent will then be in your personal Registry Forms. Please click on the My Consent link and follow the instructions to save, print or email a copy of your signed consent.

Participation in the Registry includes the following Activities:

If you choose to complete the consent process and become a Member of the Registry, you may complete any of the following online forms to support the Registry and advance uterine cancer research. In addition, Members may use the Registry website to publically share their story using the Stories link. Members may use the News link to learn about additional research opportunities as well as local, national and global events.

• Member Profile: Collects contact and user account details.
• Medical Release Form: Authorizes the release of medical reports to be submitted to the Registry for research. These reports may be from your cancer surgeries (operative, pathology, and cytology reports), including your initial cancer surgery, or reports documenting disease progression or recurrence.
• Medical Authorization to Release Health Information Form: Allows a family member, friend or clinical staff to provide cancer updates on your behalf.
• Medical Update Form: Accompanies the Medical Authorization Form and provides a simple guide to the vital information the Registry will request from whomever you authorize
• Research Form 1: A questionnaire for new Members that collects information about you and your reproductive history, medical condition, family cancer history, feelings, social support, barriers to care, physical activities, preferences and food intake.
• Research Form 2: A form for new Members that collects details about your cancer diagnosis, treatments, symptoms, and health screenings and care.
• Research Form 3: An annual form that collects new details about your cancer diagnosis, treatments, survivorship, and health screenings and care.

5. WHAT ARE THE POTENTIAL RISKS AND DISCOMFORTS?

The main risk of contributing data to the Registry is the loss of privacy and confidentiality. The Registry utilizes all available steps and procedures to protect your privacy and confidentiality. While we believe that the risk to you is very low, we cannot tell you that there aren’t any risks. The Registry protects your privacy and confidentiality by limiting the amount of personal information that we request from you to your name, email, date of birth, phone number, city, state, zip code, country and dates such as dates of diagnosis, cancer surgeries and cancer evaluations. We do not ask you for your social security number or any account numbers.

Your personal information will be used to operate the Registry and will never be given to Researchers. Researchers will only be given access to coded de-identified data from the Registry.

6. FUTURE CONTACT FOR RESEARCH

To further advance uterine cancer research, the Registry will partner with approved investigators on special Registry sub-studies and/or independent companion research projects. Members of the Registry who satisfy the eligibility criteria for these optional studies will be recruited. One planned future sub-study, for example, involves the ability for Members of the Registry to contribute specimens to further uterine cancer research. If you are contacted about one of these special optional research studies and wish to learn more, you will be instructed to view promotion materials including brochures, webpages and/or videos about the research projects. If you decide to participate in any of these optional research studies, you will be required to complete a separate informed consent. Your decision to participate in any optional research projects will not affect your care in any way and will not impact your participation in the Registry.

7. WHAT ARE THE POTENTIAL COSTS TO TAKE PART IN THIS STUDY?

There is a potential cost to you for contributing data to the Registry for research. This is only a potential cost because some hospitals and doctors charge a fee to provide copies of medical reports. If your hospital or doctor charges a fee to make copies of your medical reports, there are two options for covering this fee:

• Option 1 is for individual Members, who have the means, to pay the fee. If you have the means, you will be able to pay the fee or not.
• Option 2 is for the Registry to secure funding from donations or grants, for example, to pay the fee. If there is a fee and you opt for Option 2, you will not be sent compensation directly to pay any fees associated with obtaining copies of your medical reports. Please send an email with the details regarding the amount of the fee, and to whom the fee should be paid to ucr@endgyncancer.com. The Registry will then deal directly with the hospital or your doctor to get copies of your medical reports once funding is secured to pay the fee.

8. THERE ARE NO PAYMENTS FOR PARTICIPATION

You will not be compensated for your participation in the study. Research done with your data may help to develop new products, tests and therapies in the future that could be patented and licensed. There are no plans to provide you or your family with any direct financial compensation or other benefits.

9. THIS IS NOT A CANCER TREATMENT STUDY

This is not a treatment study. If you are seeking treatment for your cancer, please contact your doctor to obtain a referral to a qualified health care professional to get treatment.

10. WHAT ABOUT CONFIDENTIALITY?

The Registry uses a secure website and online forms to collect information about you and your cancer to operate the Registry and for research. Some of the forms will collect personal identifiers that are necessary to operate the Registry. These identifiers will never be shared with any Investigators doing research. The data that will be used for research will be stored in a secure, coded, electronic research record. If you choose to submit any medical reports, they can be securely emailed to the Registry at ucr@endgyncancer.com or via a secure encrypted eFax account at (703) 940-1390. Trained Registry staff assigned by the Principal Investigator will be responsible for the following:

• Ensuring that your electronic research record doesn’t contain your name, street address, email address, phone number, month or day of birth, medical record number, surgiopathologic accession number, or any other personal identifiers. Your electronic research record will be labeled with a coded ID (made up of unique numbers and letters) that cannot identify you. Researchers who get data from the Registry must agree to keep patient data private and confidential, and to only use the data for ethical research.
• Providing information and answering questions about the Registry, assisting with the consent process, providing member support for navigating the website, and following up with Members regarding medical release, medical authorization, and annual research forms.
• Maintaining functionality, performance, and security for the Registry website, data, and supporting infrastructure.

Portions of your data may be viewed by or given to the U.S. Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) agencies, the Western Institutional Review Board® (WIRB®) or other Institutional Review Boards, Inova Health System, Gynecologic Cancer Center of Excellence, the Henry M. Jackson Foundation for the Advancement of Military Medicine, the Uniformed Services University, Spark Media, Dataprise, and other Sponsors. Total confidentiality cannot be guaranteed because of the potential need to give information to these parties. Procedures and safeguards are in place to make this risk as small as possible. Individuals who work for these organizations are all required to keep patient data private and confidential, and to only use the data ethically for approved reasons.

Information about the Registry and results from research conducted using data from the Registry will be presented at meetings and in publications. Your protected health information will not be given to researchers and will not be included in any presentations or publications

11. HOW LONG WILL YOU BE IN THIS STUDY AND CAN YOU CHANGE YOUR MIND ABOUT PARTICIPATING OR THE USE OF YOUR DATA?

You will be able to participate in the Uterine Cancer Registry indefinitely, or as long as funding is available to continue to operate the Registry. You can change your mind about the use of your data or decided to stop being part of the Registry at any time by completing the online Change Your Consent Form and/or the Registry Withdrawal Form on the website.

12. FUNDING AND SUPPORT FOR THIS STUDY

This study is being funded by the Department of Obstetrics and Gynecology at Inova Fairfax Hospital, the Inova Research Foundation, and the Gynecologic Cancer Center of Excellence (GYN-COE).

13. WHO CAN ANSWER QUESTIONS ABOUT THE STUDY?

You can use the online appointment scheduler on the website to schedule an appointment to talk with someone about the Registry and get answers to your questions. If you have questions about your rights as a research subject or if you have concerns or complaints about this study, you may contact the Western Institutional Review Board® (WIRB®) at 1019 39th Avenue SE Suite 120, Puyallup, Washington 98374-2115, by calling 1-800-562-4789 or 360 252 2500, or by sending an email to Help@wirb.com. WIRB is an organization of people who independently review research.

14. WHAT TO DO NEXT?

If you are interested in becoming a Member of the Uterine Cancer Registry, please answer the two questions below. Then click the following link to complete the consent process. You will be asked to electronically sign and date this consent after the attestation statement. Then you will create a Member account to log in to the internal website for Members of the Registry.

Thank you for taking the time to read this consent and to learn about the Uterine Cancer Registry.

15. ATTEST AND ELECTRONIC SIGNATURE

By providing today’s date, your name and your electronic signature you attest (confirm) that
(1) You understand that participation in the Registry is voluntary and will not change your medical care.
(2) You are free to decide what you contribute to the Registry for research.
(3) You can withdraw from the Registry at any time.

Although having an email is not required, if you wish to obtain one, please click here to make a Gmail account.