2025 HCL Patient Seminar Session: Hairy Cell Leukemia (HCL) Patient Data Registry

This webinar session was prerecorded by the Hairy Cell Leukemia Foundation with guest speaker Dr. Mirela Anghelina from the Ohio State University. Dr. Anghelina discusses the HCL patient data registry, including how patients can join, studies underway using the data, and efforts to expand participating sites.

View a Recording of Dr. Mirela Anghelina’s Presentation Below

Important note: As of June 2025, there is a temporary pause on enrolling new patients in the HCL patient data registry. OSU is currently training and onboarding staff and registry enrollment will resume soon.

Transcript of Dr. Anghelina’s Presentation

I'm excited to share some updates on Hairy Cell Leukemia Registry with you today. I want to thank the Hairy Cell Leukemia Foundation for having me today.

I am Mirela Angelina. I'm a senior research data analyst at Ohio State University. Dr. Michael Grever is the principal investigator of this project at the Ohio State University.

The Hairy Cell Leukemia Patient Data Registry is a project shaped and funded by patients since 2012. It was created by the Hairy Cell Leukemia Foundation in collaboration with the Ohio State University Hematology Division and Center for Biostatistics to improve awareness and knowledge of the disease and support future research efforts, with the goal to promote wellbeing among patients with hairy cell leukemia.

What is a registry?

I have here the NIH definition of the registry. In simple words, a registry is an organized collection of information about people for a specific purpose like tracking a disease, monitoring treatments, or studying health outcomes.

Why do we need a registry?

A registry is very useful for different areas like research, patient care, medical education, public health and drug development. For research, a registry can be used to study different diseases, especially rare cancers. In patient care, the data collected on patient medical history is great information to help doctors and researcher improve the quality of care for patients.

It's an important tool for medical education. The registry can provide public health officials with information to monitor and assess population health and can help pharmaceutical developers to understand the demand and value of their products.

How do we protect the data we collect in the registry?

The main goal is to protect the confidentiality and the integrity of the data. Only authorized individuals can access data and data must remain accurate and unaltered.

What strategy we use to protect the data: First, all human subject research projects are reviewed, approved and monitored by an institutional review board, or IRB, that is present at any research institution.

We also de-identify or code the data. That means we take all the patient information out of the medical records. We don't store patient names, date of birth, address, or phone numbers and we monitor the access to the data.

We restrict the number of people who have access to the data and we monitor their access.

What is an IRB?

An Institutional Review Board (IRB) is a group of people who review research studies to make sure they are safe, ethical, and respect the rights of participants. The IRB checks to make sure people are not harmed and that they understand what they are agreeing to. Their privacy is protected and the study is fair and necessary.

Who is on the IRB committee? It is usually scientists, doctors, and healthcare professionals. Also people from the community.

An IRB committee usually has patients or leaders of certain groups or important people from the community like priests, educators and lawyers. All our research is reviewed, approved and monitored by the IRB. All personnel and researchers are trained and approved by the IRB committee.

The registry is hosted at the Ohio State University, inside of the Ohio State University firewall. All the institutions have their own account. It is password protected and researchers from one institution cannot access the data from other institutions’ accounts.

De-identified copy from each participating site is uploaded in the central registry, and only this information is available to researchers. So, in the central registry, we have only de-identified patient data.

How can you participate in the registry?

There are two ways to participate.

You can enroll at the center of excellence that is participating in the study or you can enroll via the web portal if you are not treated at a participating site. So, the web portal, you can find it on the Hairy Cell Leukemia Foundation page.

On the patient support page, you can find more information about the patient data registry and you can join the registry by filling out this form where you give us your name, email address, and phone number.

If you complete this form, it doesn't mean you are enrolled in the registry. It is only a way for us to get in contact with you. This information will go to the Ohio State University and one of our clinical research coordinators will contact you and talk with you about the registry. We'll answer any questions you have about the registry and if you feel comfortable, our clinical research coordinator will guide you through the consent process.

So if you want to participate, you will sign an informed HIPAA consent form and you'll provide a release of medical information authorization. You'll provide us with your treated physician name and contact information. We will contact your physician and request medical records upload your medical information into the registry.

Once in the registry, we will update your information once a year or if there is a major change in your health.

I have here the current registry participation. To the left I have the current active participating sites. We have four sites from the US, one from Canada, and one from Australia.

There is Ohio State University, University of Rochester, University of Miami, and Mayo Clinic from United States; CancerCare Manitoba from Canada; and Peter MacCallum Cancer Center from Australia.

On the right I have five more centers; they're in the process of getting all the paperwork for joining the registry. We hope we have them joining us at the beginning of next year. There is a new site from British Columbia from Canada. Two more sites from the US, Mount Sinai Medical Center and Scripps Health. One site from the UK, Royal Marsden Hospital.

And our first site from South America is the Academy National de Medicina from Argentina. It's the first site from a non-English speaking country. We are very excited to let you know that we modified the registry to accommodate non-English speaking countries. And we hope to use this model to make it available for other non-English speaking countries from around the world.

Here, I have the geographic distribution of enrolled patients at OSU. At OSU, we have the patients who are enrolled through the Hairy Leukemia Foundation website.

There are 1081 enrolled patients in the registry so far. It’s a big number for a registry for a rare disease. There are 842 medical records already uploaded in the database.

There is a little bit of backlog there. But we are working to decrease the number in the backlog.

Here I have the demographic distribution of the patients who are already in the registry. The median age of diagnosis for our patients is around 54 with the range between19 and 96-year-old.

One third of the patients in the registry are younger than 50. At the time of diagnosis, the majority of patients are male. However, a quarter of enrolled patients are female.

We are happy to see an increased number of patients of Hispanic heritage and black or African American patients enrolled in the registry. These numbers are higher than last year. Again, this is because of the Hairy Cell Leukemia Foundation’s work to spread the word in the community about this important project.

Here, I have some clinical study we published already. The clinical study used the information we have in the registry. We published a paper where we described how we created this registry. Also, we analyzed the quality of life of patients living with this disease in collaboration with their health information from the registry.

We have a quality-of-life study in parallel with our registry and we corroborate their quality-of-life score with the health information present in the registry.

We also looked at the impact of sex on outcome in patients with hairy cell leukemia. And we looked at the outcomes of patients with Hairy Cell Leukemia who contracted COVID, also using the important information provided by the patient data registry.

We have four institutions that requested data for six different proposals. We are in the process of getting IRB approval for these six proposals. As I told you, any new proposal has to be reviewed and approved by the IRB, the Institution Review Board.

And we plan to use the data from the registry to analyze the quality of life; we are planning to do an interim analysis of this data using the health information from the registry.

I'm going to conclude by thanking our patients for trusting in us and sharing their story with us, the Hairy Cell Leukemia Foundation for all the support, all our collaborators from all participating sites and to my colleagues from Ohio State University. And I am ready to take any questions.

Transcript of Q&A

The following is an edited summary of a discussion between Dr. Mirela Anghelina and HCLF staff.

What questions do patients frequently ask during the initial enrollment discussion with Ohio State University registry staff?

Patients want to know what information we get from their medical records. We explain that we need the doctor notes, all their symptoms, the labs, pathology reports and the treatments and the conclusion of their doctors of the outcome of their treatment.

We emphasize that we don't collect their personal information. We don't need their name and date of birth. We need their age, but not date of birth. For our research, we do need the date of the medical encounters. That is necessary to have a timeline of their disease.

Patients ask if we share this information with their insurance because they are afraid that their insurance is going be affected by participating in the registry.

We do not share this information with their insurance.

Patients want to know if they have to call their doctor and get the information to us, and we tell them no. We just need your authorization to be able to contact their provider. We will contact the provider and request the medical record. They don't need to do that.

Patients often ask how do they know that we got the information from their doctor? This is a little bit tricky. We do not have a way to let them know every time when we contact the provider.

Sometimes patients ask the provider, did the Ohio State University contact you to get the information? And the doctor usually says, no. We explain to the patients that we do not contact their doctor directly. We contact the medical record office with their authorization and consent form. The medical record office will disclose their information.

If someone asks HCLF staff to confirm their participation in the registry, HCLF staff can't be a liaison between the patient and OSU. HCLF staff can put the patient in direct contact with the OSU registry team, and from there OSU will communicate directly with the patient and leave the HCLF entirely out of it. This is due to regulations regarding patient confidentiality.

Patients often ask, how do I know I'm still in the registry? We tell them the participation in the registry has no time limit, unless the patient contacts the OSU and asks to be removed from the registry. Other than that, there is no time limit. So once a patient agrees to be enrolled, they will be part of the registry.

How can patients communicate to the Ohio State University that they have experienced changes in their health?

We don’t ask patients to inform us when there is a change in their history. We will find out yearly when we do the update.

How are cancer centers evaluated as potential sites for contributing data to the registry?

First of all, we want all HCL Centers of Excellence to participate. If a cancer center is not an HCL Center of Excellence, it has to be evaluated by the Hairy Cell Leukemia Foundation. And from there, we can discuss how many HCL patients are seen at that center and how many doctors are treating HCL patients.

Where can patients access papers that have been published using registry data?

All the papers published are posted on the Hairy Cell Leukemia Foundation website so they can find these papers there.

The Hairy Cell Leukemia Foundation gets the word out through the newsletter, links to published research on its website, and invites investigators to present their published data in webinars and seminars for patients.

Is there a target enrollment number for the registry?

Not a target number for enrollment. However, we have target numbers for certain projects. For example, we want to do a new staging of the disease study. For that, we need 1,000 people. We reached that, but we don't have the medical records ready to be used.

For each study, we do a power calculation and establish the number we need for that study to be statistically significant.

How does the Institutional Review Board (IRB) limit how OSU registry staff can communicate with enrolled patients?

If we are going to contact the patient after enrollment, we have to keep the IRB informed about any communication we have with the patient. Any email, phone message, or other communication has to be approved by the IRB before it goes out.

So instead, we choose to keep the patients informed with our research activity through the Hairy Cell Leukemia Foundation website.

All the studies we are running using the patient's data from the registry are shared through the Hairy Cell Leukemia Foundation website. Of course, if any patient contacts us and wants to know about any study that was conducted or published using HCL registry data, we can share the publication with them if they contact us directly, but we cannot contact the patients every time we conclude the study and let them know what we found.

HCLF staff will let them know when there are studies that have been approved and then anytime the data's published, HCLF staff can communicate that information through the HCLF newsletter and social media, as well as through HCLF educational programs.

How are the HCL Patient Data Registry and quality of life study connected?

The quality-of-life study is a companion study to the patient data registry. It uses registry data but is a separate study from the registry.

The transcript was edited for clarity.