We recognize that sharing your health information can be a difficult choice, we want to make sure that you feel comfortable providing this information and wanted to address some of the frequently asked questions below. Your contribution to the ACCELERATE Registry is greatly appreciated and the ACCELERATE Registry Team is going to great lengths to ensure that your data is kept private. If at any point you have questions about your participation in this research registry, you should call 215-349-5713.
Once you have registered for the registry, please make sure to complete the every 3 month patient survey and encourage your physician to complete their every 3 month physician survey. If you would like, the Accelerate Registry Team has provided a template letter that you can hand to your physician here.
Frequently Asked Questions (FAQs):
The ACCELERATE Registry is designed to collect medical information about Castleman disease and patient-reported information in order to better study the disease
ACCELERATE is a registry for patients with Castleman disease. If you are a patient or a family member of a deceased patient with Castleman disease, you may be eligible to participate. Participation will require a pathology report that suggests “Castleman disease.”
You will be directed to an online portal where you will be asked a few questions about your eligibility to participate in this study. Should you be eligible to participate, you will be asked to read through and complete an informed consent form that will further explain the study. Completion of the consent form is required for participation in the study.
Once you have completed the consent form, you will be directed to additional online questionnaires, which will ask you important questions about your contact information, demographic information (age, race, sex, etc.), diagnosis information (date of diagnosis, subtype, etc.), family history, and information about hospitalizations and physicians that you have seen for your Castleman disease. You will also be asked to upload a pathology report suggesting “Castleman disease.” Doing so will greatly increase the speed with which we can confirm your enrollment into the study.
After you have completed all of the forms, your information will be directed to us and we will begin seeking your medical records. If you were able to upload a copy of your pathology report, we can confirm your enrollment into the study. Otherwise, we will need to seek a copy from your physician.
Once your enrollment is confirmed, you will be sent an email every 3 months asking you to complete a few brief questionnaires about how you’ve been doing, your recent medications, and your recent hospital and clinic visits. Because it is important that we obtain accurate information, we may also ask you to review and confirm certain information about your medical history. We will continue to seek your medical records in order to better understand your experience with Castleman disease.
If at any point during the study you have questions about your participation, we encourage you to reach out to us at 215-349-5713.
If you have previously sent your name and contact information to the CDCN, you have been included on our mailing list. We will contact you to enroll in this study, however you will not be automatically enrolled into the study unless you complete the registration at www.cdcn.org/accelerate.
There are four parts to the Registry:
- Medical Record entry, where the ACCELERATE Registry Team will request and extract data from patient medical records into the registry,
- Patient Portal, where patients can fill in surveys and share their own experiences with Castleman disease,
- Physician Portal, where doctors can enter data about Castleman disease patients under their care, and
- Lymph Node biopsy review, where the ACCELERATE Registry Team will request your excess lymph node biopsy tissue to be reviewed by a subcommittee of experts.
If you decide to participate in ACCELERATE, we will ask you to share the following personal health information to be used for research:
- Contact information (address, email, telephone number)
- Date of birth
- Location of birth
- Family medical history
- Information from past and current medical and medicine history, including Human Immunodeficiency Virus (HIV) test results
- Information from laboratory tests, including dates
- Information from surgical procedures, including dates
- Current and past treatments
- All hospitals and physicians you have seen
- Answers to survey questions that you and your physician provide
- The last 4 digits of your Social Security Number
- You will have the option to consent to sharing your full Social Security Number that will be stored to assist with collecting medical records
Your name, date of birth, and location of birth will be used to create a Global Unique Identifier (GUID), a computer-generated alphanumeric code unique to each research participant. This will be used in order to protect your identity. Your personal health information will be collected to help with our understanding of Castleman disease. Your data will be protected in a variety of ways. All transmission to and from the database is encrypted and password protected. The IT system uses Advanced Encryption Standard (AES) algorithms to store sensitive data. AES is the first publicly accessible and open cipher approved by the National Security Agency (NSA) for top secret information. Web traffic is only served over HTTPS with strict TLS encryption. The IT system uses external tools to verify that best practices are being followed and the system consistently scores an A grade for SSL encryption setup. The platform is deployed with a data center that has gone through arduous certification and external audit processes. This data center also boasts the first Tier III certified data center in Canada and represents the best in breed of security and redundancy.
No, we will assign a coded number, Global Unique Identifier (GUID), developed by the National Institutes of Health (NIH) to your medical record information stored in the Registry and will use that code instead of directly identifiable information.
All paper documents (e.g. original medical record documents) will be stored within a locked filing cabinet located in the ACCELERATE team offices in the Hospital of the University of Pennsylvania (HUP). Some of the medical records may be transferred to a secure, HIPAA compliant, off-site records management storage facility.
Electronic medical record data will be automatically sent to and integrated into the registry, a secure, web-based application. All transmission to and from the database is encrypted and password protected. Strongly characterized credentials are provided and bad login attempts will lock users accounts. Timeout periods are enforced and all actions are logged. The platform only allows users from email domains for their organization. The registry database will be maintained behind Pulse InfoFrame’s firewall. The IT system uses Advanced Encryption Standard (AES) algorithms to store sensitive data. AES is the first publicly accessible and open cipher approved by the National Security Agency (NSA) for top secret information. Web traffic is only served over HTTPS with strict TLS encryption. The IT system uses external tools to verify that best practices are being followed and the system consistently scores an A grade for SSL encryption setup. The platform is deployed with a data center that has gone through arduous certification and external audit processes. This data center also boasts the first Tier III certified data center in Canada and represents the best in breed of security and redundancy. The IT system will employ multiple security features to limit access to any PHI to study team members who have completed CITI Human Subjects Training only. Data containing direct identifiers will not be available for export at any time.
We believe the risk of loss of confidentiality is very small as access to your information is limited and we have in place strict electronic security measures (electronic data) and physical security measures (physical data). Access to your protected health information is limited to selected and qualified study personnel:
- Principal Investigator
- The research team at the University of Pennsylvania
- Authorized University of Pennsylvania personnel
If during review of your records, physicians and researchers determine that your medical records and biopsy samples strongly suggest that you have a clinically-actionable and life-threatening disease other than Castleman disease, you will be contacted and informed of this finding. However, no other records will be shared with you.
If you stop the study early, the study information that was obtained up until that time will still be used for research purposes and will be protected by the same above mentioned measures.
If at any point you have questions, concerns, or complaints about your participation in this research registry, you should speak with the Principal Investigator, Dr. David Fajgenbaum at 215-614-0936. If the Principal Investigator or a member of his team cannot be reached, you may contact the Office of Regulatory Affairs at the University of Pennsylvania by calling (215) 898-2614.