INFORMED CONSENT
The Appendicure Patient Registry
Study Name: The Appendicure Patient Registry
Protocol Number: APPEND-REG-001
Sponsor: Appendicure
Principal Investigator: Amanda Moore, Executive Director
Contact: info@appendicure.com
Key information about this registry
This is a research study (a registry) for people who have been diagnosed with appendiceal cancer. We are asking you to take part. Before you decide, please read this short summary.
What is the registry? A long-term collection of health information from people with appendiceal cancer. The goal is to learn more about a rare cancer and to support better care for patients.
What will I do? Fill out an online questionnaire about your diagnosis and treatment, upload a copy of your pathology report, and answer follow-up questions about every six to twelve months. Everything is online. There are no clinic visits, no medications, and no samples.
How long will it take? The first questionnaire takes about 30 to 45 minutes. Follow-ups are shorter. You can save your progress and finish later.
What are the risks? The main risk is that your information could be seen by someone who should not see it. We have strong protections in place to keep this from happening (described below).
What are the benefits? There are no direct medical benefits to you. Your participation may help future patients with appendiceal cancer.
Do I have to take part? No. Taking part is your choice. You can skip questions, take a break, or leave the registry at any time.
If you want more details, please read the rest of this form. You can ask us any questions before you decide.
Why is this registry being done?
Appendiceal cancers are rare. Because they are rare, doctors and researchers do not have as much information about them as they do for more common cancers. This makes it harder for patients to get clear answers about their disease and the best ways to treat it.
Appendicure is a patient-led group that supports people affected by appendiceal cancer. We are creating this registry to collect information from many patients in one place. The information will help researchers and doctors learn more about appendiceal cancer, including how it acts over time, what treatments people receive, and how patients do.
We also want to use the registry to support a request to a national group called the NCCN to update their treatment guidelines. Specifically, we want to support better insurance coverage for a class of drugs called CDK4/6 inhibitors for patients with a certain type of appendiceal cancer that has a GNAS mutation.
Who can take part?
You can take part if:
- You are 18 years old or older.
- You have been diagnosed with any type of appendiceal cancer.
- You can give us a copy of your pathology report.
- You can read English and give your consent online.
What will you do if you take part?
Step 1: Fill out a first questionnaire. After you sign this form, you will fill out a questionnaire on a secure website. We will ask about basic information about you (age, sex, where you live); your diagnosis (type of appendiceal cancer, when you were diagnosed, stage); your treatments (surgeries, chemotherapy, other medicines you have taken); your doctors and treatment centers, if you want to share that; and how you have been feeling and your quality of life. You will also upload a copy of your pathology report. We use the pathology report to confirm your diagnosis. This first questionnaire takes about 30 to 45 minutes. You can save your progress and come back later.
Step 2: Answer follow-up questions. About every six to twelve months, we will send you a shorter follow-up questionnaire. We will ask if anything has changed (new treatments, how you are feeling, any new diagnoses). You do not have to answer every follow-up. If you skip one, you are still in the registry.
Step 3: Stay involved as long as you want. You can stay in the registry as long as you want. You can leave at any time.
What will Appendicure do with your information?
Your information will be added to the registry. We will use it for research about appendiceal cancer.
We may share your information with research partners at major cancer centers, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and the University of California San Diego. These partners help us with the research and the planned NCCN guidelines submission.
When we share information with research partners, we follow these rules: Appendicure stays in charge of the registry. Partners only get access to the information they need for their part of the research. When we can, we share information without your name and other identifiers attached. When we publish results from the registry (in journals, at conferences, or in patient-facing summaries), we will not include your name or anything else that identifies you.
What are the risks?
This registry does not involve any treatment, medication, or procedure. There are no physical risks to you.
The main risk is that someone could see your information who should not see it. This is called a privacy breach. To lower this risk, we use a secure online platform (Jotform) that is set up to protect health information. Your information is locked behind passwords and is encrypted (scrambled) when it is stored and when it is sent. Only people at Appendicure who need to see your information can see it.
Some questions in the registry may bring up difficult feelings, especially if they ask about your diagnosis or how you are feeling now. You can skip any question you do not want to answer. You can take a break and come back later.
What are the benefits?
There are no direct medical benefits to you from being in this registry. By taking part, you may help future patients with appendiceal cancer. You may also help support a request to NCCN that could improve insurance coverage for certain treatments.
Will it cost me anything? Will I be paid?
There is no cost to you for being in this registry. You will not be paid for taking part.
How will my information be protected?
Your information is stored on a secure online platform (Jotform) that meets U.S. health privacy standards. Appendicure has a special agreement with Jotform (called a Business Associate Agreement) to protect your information.
Your information is encrypted when it is stored and when it is sent. Only certain people at Appendicure can see your full information. They use passwords and two-step verification to log in.
Use of your health information (HIPAA Authorization)
Some of the information you give us is protected by a U.S. law called HIPAA. By signing this form, you give Appendicure permission to: collect the health information you provide (including your pathology report); store this information in the registry; use this information for the research described in this form; and share this information with research partners at MD Anderson, Memorial Sloan Kettering, the University of California San Diego, and other partners we may add in the future, in support of the registry's research goals.
This permission does not have an end date. You can take this permission back at any time by emailing info@appendicure.com. If you take this permission back, we will stop collecting new information from you. We will keep the information we already have and remove things that identify you (your name, contact information, and any other direct identifiers), so that the remaining information cannot be linked back to you.
Once we share information with our research partners, we cannot get it back from them. The consent you give covers this. After you take your permission back, we will not share any new information with our partners.
Once we remove things that identify you, the law no longer protects that information in the same way. We will continue to protect it carefully and use it only for research.
What if I want to leave the registry?
You can leave the registry at any time. You do not have to give a reason. To leave, send an email to info@appendicure.com. Tell us you want to withdraw.
When you leave: We will stop collecting new information from you. Information we already have in the registry will stay, but we will remove your name, contact information, and any other direct identifiers, so the remaining information cannot be linked back to you. Information that we already shared with research partners before you withdrew cannot be taken back from them. After you withdraw, we will not share any new information with partners.
Is taking part really my choice?
Yes. Taking part in this registry is your choice. If you decide not to take part, nothing changes. You will still get all the support and resources Appendicure offers to people with appendiceal cancer. Your medical care will not change. If you take part and then change your mind, you can leave at any time.
Who can I contact with questions?
If you have questions about the registry, the way your information is being used, or anything else, contact:
Amanda Moore
Principal Investigator, Appendicure
Email: info@appendicure.com
If you have questions about your rights as a research participant, or if you want to talk to someone who is not part of the research team, you can contact the Advarra IRB:
Advarra IRB
Email: cirbi@advarra.com
Phone: 1-800-261-3458 (US number; international participants please use email)
Your decision
Please read each statement below. By checking the box below and submitting this form, you are saying that you understand and agree.
I confirm that:
- I have read this consent form, or someone has read it to me.
- I have had a chance to ask questions, and my questions have been answered.
- I understand that taking part is my choice.
- I understand that I can leave the registry at any time.
- I agree to give Appendicure my health information for the research described in this form.
- I agree that Appendicure may share my information with research partners as described in this form.
- I am 18 years old or older.
If you check the box below and submit this form, your electronic signature has the same legal effect as a handwritten signature. After you submit, we will send you a copy of this consent form for your records.