Alicia Morgans: Hi, this is Alicia Morgans, Associate Professor of Medicine and GU Medical Oncologist at Northwestern University. And I am so excited to have here with me today some of the people who've put together the COVID-19 cancer registry. I'd love to hear them each introduce themselves while we talk about the importance of this and what this registry is really doing for oncology and for GU cancer specifically. So go ahead, guys.

Petros Grivas: Hi, Alicia. This is Petros Grivas. I'm a medical oncologist at the Seattle Cancer Center Alliance and an Associate Professor at the University of Wisconsin, Associate Member of the Fred Hutchinson Cancer Research Center. I can start giving you a background of what the effort is and what the need is and then I will let Jeremy and Ali make some more specific comments about it. So I think the context here specifically for the audience who deal with the management of genital urinary cancers every day is the challenge we have every day is how to make decisions, informed data-driven, evidence-based decisions in the context of COVID-19 pandemic that I think it's skewing every decision we make for our patients every day.

Just to give you some examples. As you know yourself, in practice we deal with patients with kidney cancer, urothelial cancer, testicular cancer, prostate cancer. Now there are different modalities, surgery, systemic therapies, radiation therapies, so and so forth. And the question is how do we prioritize those therapies? How do we make informed decisions every day? But also what are the risk factors for patients with cancer? How do they contract the disease? How can we potentially use that information in the future to avoid exposure to patients? And of course, all those scenarios are very challenging.

As you know, there have been very, very limited data sets addressing those questions. And to my knowledge, there had been only minimal reports. There's only like a cohort of 18 patients, I think from China with I think only half of them are receiving cancer treatment. It showed that these patients with cancer have a higher risk of complications of COVID-19. So there's definitely an urgent unmet need to understand more of the situation with COVID-19 and cancer.

So to address this unmet need that is this consortium that we put together in order to generate data in real-time as we go in the next few days to weeks and be able to help providers across the nation and internationally understand this better and potentially make decisions. So I will let Jeremy and Ali introduce themselves and make some more detailed comments about how this effort generated and came through and where we stand right now. Thank you.

Jeremy Warner: Thanks, Petros. This is Jeremy Warner. I'm an Associate Professor at Vanderbilt University Medical Center. So I'm also an informatic person here, informaticist informatician. Those are fancy words for kind of glorified data scientist. We like to work with data of all kinds, and I've been doing that for many years as well.

Ali Khaki: Hi, my name is Ali Khaki. I'm a third-year hematology-oncology fellow at the University of Washington, Fred Hutchinson Cancer Research Center in Seattle. I do genitourinary research, especially with bladder cancer. And I've been doing a lot of work with Dr. Warner and getting this registry off the ground. But we've been working together the last 10 days trying to put this consortium together, and we're excited to be able to share with you on the progress we've made so far.

Alicia Morgans: Great. And welcome everybody and thank you so much for taking the time to do this. And always good to talk to you, Jeremy. We did start out together at Vanderbilt a long time ago, but certainly have continued to grow and you have grown really your bioinformatics program so adeptly. And it'd be great if we, as an audience, could understand what are the aspects of this registry? How do people really engage? What are you capturing? What do we need to know?

Jeremy Warner: Sure. We're inspired by a couple of things. One thing is the cancer registry network in the United States and your audience may not be familiar with it because it often is sort of a behind-the-scenes activity at hospitals and at the state level and at the federal level. But there is this very large and well-established cancer registry program. And one of the well-known versions of this is the NCI SEER program, which basically collects detailed information about cancer patients across about a third of the country. Cancer is actually a reportable disease. People may not realize that. That's enshrined in the National Cancer Act and back in the 1970s. So there's this system which I've been immersed in many years. And then there's also informatics technologies at the institutional level and sort of in this general area of what's called clinical research informatics.

And perhaps the best known of those systems is something called REDCap, which was invented here at Vanderbilt a little bit over 10 years ago. And it's Survey Monkey on steroids, but it's really got a lot of bells and whistles. It's got privacy protections if you need it. It allows for many multiple users to enter data at the same time. It's highly flexible and customizable. So I basically took advantage of the infrastructure that we already had here as well as my familiarity with the registry system to really try to launch this quickly.

The other thing that I was inspired by, or perhaps I'm the opposite of inspired, are the reporting systems that are out there for clinicians to voluntarily report adverse events, for example. So it's the FDA Adverse Event Reporting System. It's extremely cumbersome, can take 30 minutes, an hour to enter a case. As a result, they really don't get a lot of information going into that system. So what we really wanted to design from the ground up here was something, it could be quick but granular, and it could be something that a clinician could jump into, web-based sort of in their native environment if they're using one of the big EHR vendors. Just fill out the forms, get it done in less than five minutes, and start adding information to this registry. So that was some of the inspiration. Ali, do you want to talk more about where it came from social media?

Ali Khaki: This also had been happening about 10 days ago. The weekend before last, there was a bunch of oncologists and trainees discussing the need to better understand the clinical course for cancer patients with COVID-19 and Aakash Desai who is a medical resident at UCONN, took the initiative to convert these Twitter conversations into an email and reached out to myself, Dr. Warner, and a few other collaborators who were active on the initial Twitter conversations suggesting that we move to try to develop something.

And from there, Dr. Warner, because of his resources at Vanderbilt was able to sort of quickly get a REDCap set up and begin that conversation further. That initial email has now blossomed to an email that has many, many more collaborators. I think Jeremy was telling me earlier today that there are over 70 people now at 35 institutions, so it's pretty remarkable how over the course of 10 days we've really grown. And the collection tool now is a four-page survey. And if you only do the required data elements can be done try again in a couple of minutes. But we also have the ability to collect a lot more information for people who have the time to give us a little more granular information about their patients.

Alicia Morgans: So Ali, just a quick question before we move on to asking Petros some questions. As you think about this registry and the research that you're doing, the clinical care that you're providing, what are some of the questions you think that you'd like to answer, as it becomes more mature after it's gotten its self off the ground a little bit?

Ali Khaki: Yeah, I see this initially as mostly being a descriptive sort of study to really just understand what is the treatment course, what is the clinical course of patients with cancer who get a COVID-19 infection. As was mentioned by Petros, the data we have today, there's a study out of China that had 18 patients, only five of which were getting active treatment but did suggest that cancer patients were having worse clinical outcomes with COVID-19. So we'd want to have more data to get at that, to understand that better. We also captured data elements about the treatment course for COVID-19 patients. Are they getting things like tocilizumab or remdesivir or other agents that are under investigation or are being used even off trial at some institutions? So understanding if we're seeing a signal of which or if any of those work.

And then also trying to understand if there's an association with particular cancers that's leading to particularly poor outcomes, understanding sort of that full spectrum of what is driving especially poor outcomes with COVID-19 will be enlightening for us as we sort of think about clinical decisions moving forward, about should we be more aggressive with isolating particular patients more so than others? Or are there certain things we should be doing? Should we be stopping immunotherapy for certain populations? Should we not be starting chemotherapy where there's a minimal benefit and the risk is too high?

So I think that once we start describing at least what we understand about COVID-19 in our populations, we can sort of start making the next level decisions of how they should change or inform our care.

Alicia Morgans: You know, Petros, you have always had very much a way of bringing people together, not just at your own institution but certainly across the nation and internationally. And I know it is a goal of yours and of the teams to bring this registry really beyond the borders of the US and to engage and involve as many clinicians and include information about patients as we possibly can from around the world. How are you taking steps to do that?

Petros Grivas: Thank you, Alicia, for the kind words. Always strength of the work is in the pack, which means that the strength of the team is worth much more than the individual. So it's always the principle that guides our actions.

So to answer your question specifically, all of us are literally striving to make this effort as global as possible and involve colleagues from multiple academic institutions, community oncology settings in the country, but also internationally to your point. So this consortium called the steering committee, which involves a number of esteemed colleagues. And we're actually very, very happy to work all together and we can even forward you the list of those individuals. And Jeremy and I are part of the steering committee and we had calls, many calls in the last two weeks. And one of the items we discussed was how to optimize international outreach. And we actually have tried to identify some countries that can be "selected" first taking into account some regulatory restrictions and limitations.

And we pilot this international outreach initially with six countries and to try to see if we can gather data from them. So we did select six countries and we reached out to them in order to get some traction and get contacts there throughout our collaboration and colleagues we know. So we're hopeful that we'll be able to, in the first stage or phase, be able to generate data from those six countries. And we tried to be selective for countries who have high incidence and prevalence of COVID-19 for example, countries in Europe, like UK, Italy, Spain and Germany as well as South Korea in Asia and also Brazil in South America so we can have a broad [inaudible] geographically as well as equal diversity.

This is still in the works and we try to, of course, overcome regulatory hurdles, but we're hopeful to be able to engage those colleagues and eventually get even more countries into this effort to generate as much data as possible. Jeremy can comment more on that.

Jeremy Warner: Yeah. Just briefly, I just learned just a few minutes ago that the UK has launched its own coronavirus and cancer monitoring project, and they have their own websites and centers involved. So it's great. I think the challenge here is going to be, we're all putting up these efforts quickly. There's also other efforts that are more disease-focused going on nationally and internationally. We've all got to try to harmonize our data models. I'll just speak with my informatics hat on for a minute. If we don't work hard on being interoperable, there's no way we're going to get our data to combine and to make sense of it.

So we're trying to work ... whether or not the countries are formerly part of the CCC19 consortium or if they have their own efforts, it's still a possibility that we can share data and learn at scale because really what we're trying to learn is we've got a subset of a subset of a subset which would be cancer patients who have COVID-19 and are ill from it. Because remember a substantial number of people will have mild disease. So the numbers are going to be substantial, but we really need to combine forces both here domestically as well as internationally to try to learn as much as we can about what factors are really driving the risk in cancer patients.

Alicia Morgans: So wonderful. And just to translate Jeremy's comments on interoperability and really standardization. Just that I think we want to make sure that we harmonize and collect the same elements of information for patients across all registries if we can so that at the end of the day we can pull all that data and pool all that data and if all the same elements are collected, we'll be able to pool them most effectively, which is something that's really interesting.

And really to piggyback on the last thing you said, because this is something that in my clinical practice I worry about a little bit. I understand that this registry is really for patients who have cancer who have COVID-19 and who are symptomatic from it, but is there an opportunity as time moves on and you are able to sort of expand this registry even further to also collect potentially information on patients who are either asymptomatic or minimally symptomatic so we can round out our understanding? It is very possible that asymptomatic or minimally symptomatic patients could be coming into our clinics and potentially infecting or affecting other patients or family members or clinicians around them. And I think we really don't quite have a handle on that group of people at this point either. And it would be nice to have that information within the registry if possible, though it may be out of scope. So just curious about that.

Ali Khaki: I can talk about that for a second, Alicia. The way our tool is built right now, we're interested in collecting data on anyone who's got COVID-19, and one of our pages in our survey where we ask questions about the severity of disease and the clinical course. And so we would certainly welcome any patients with COVID-19. And even the way that we collect that data, you don't have to be COVID-19 test positive. We even asked what is the source of the diagnosis? Is it based off of a CT scan? Is it based on clinical suspicion or based off of a nasal pharyngeal swab test? Because I think that it is important for us to sort of understand the full spectrum of the disease and not just the most severe cases. That will help inform all of our analyses as we try to sort of best understand this disease in our cancer patients.

And you could even hypothesize there might be people who are minimally symptomatic, but then once they get an immune checkpoint inhibitor, they have a particularly severe immune-related adverse event. And that might be that COVID-19 even minimally symptomatic could lead to some bad adverse events with our therapies. So those are the things we'd want to know. And the only way you can identify that is if we capture that data.

Alicia Morgans: I completely agreed. Go ahead.

Jeremy Warner: I want to emphasize that this disease is affecting all of our patients already. We shut down clinical trials today at Vanderbilt. I've obviously never seen anything like that before. We just felt that there was no longer the staff to support it, the risk benefit was changing. But NCCN recommendation on every page is a clinical trial. Right? So we're ready already facing effects on the care of cancer patients more broadly than just those that are affected. We have a narrow focus right now, but certainly many members of this consortium are thinking about the effects on all cancer patients, and additionally, some cancer patients are healthcare workers and understanding the effects on those people who are even been more vulnerable is another focus perhaps of the future of this consortium.

Alicia Morgans: I completely agree. And of course, it's important, I'm sure that we enroll a diverse population of patients. We're aiming for the globe, but minority patients, social and ethnic minorities, racial and ethnic minorities, I think will be really, really important to ensure that we understand the diversity of people that exist. And I commend you for all that you're doing with this. So as we wrap up, I'd love to hear final thoughts and messages from each of you. Maybe in the same order in which you talked earlier, starting with Petros.

Petros Grivas: Thank you, Alicia. I think the take-home message is everybody is welcome to participate in this registry. Jeremy mentioned that we'll have more than 70 sites, but this is open to everybody. Health providers can access the website and the survey, can enter data, and this can happen I think almost real-time will help inform the direction and they can help disseminate these efforts nationally while we're also trying to do that internationally on our end. And also I want to also add that we have discussions with NCI and also some other organizations on how to optimize that data collection and for the long term provide support and potential help with data analysis. So I think the take-home message is keep that in your mind and to try to enter data across the nation. Thank you for all the support here.

Jeremy Warner: Thanks. Yeah, thanks for having me. I will just say visit our website. I think a link will be provided with the story, but if not at CCC19US.org. And soon we'll have CCC19.org. That's in progress. What you need to access the surveys is right there on the website. I also want to emphasize that this survey can be filled out and then updated by returning to it and adding more information. So if you're a healthcare provider or planning to report, you don't necessarily need to wait until that patient's course of illness is complete. You should probably consider going in and starting to fill in the survey as soon as you think of it.

And I think this is really going to benefit patients foremost. That's really what we want to do. We want to release this information as quickly as possible, especially if we find signals for either especially dangerous situations, but also if we see signals of perhaps some of these experimental treatments that are being tried at many medical centers, sort of anecdotally, hopefully, we can start to see signals of if those are helping or not. And we plan to disseminate those findings as quickly as we can.

Alicia Morgans: Wonderful. And Ali?

Ali Khaki: Thanks, Alicia. Thanks to UroToday. I've been really just moved by all the people who have come together for this project so quickly. Like literally I'd mentioned before from six people to over 70 at multiple different institutions, large national efforts that are being put into this in just under 10 days. And so I think that with that sort of collaboration, great things can happen and I'm excited about what we will be able to do with this. So I welcome everyone to come work with us and join us, CCC19US.org. Thanks.

Alicia Morgans: Wonderful. So please go to the website, consider entering data for your patients. And if you have any questions, please reach out to these guys and ask them. There may be some minor hurdles that you or your institution need to do in terms of IRB and those kinds of things. So ask the question so that you can participate and hopefully for a majority of people who are interested, there will not be IRB issues. But just to stay on the right side of everything, please ask those kinds of questions and make sure you know the answer before participating. But in general, please participate. It will be great to get this registry off the ground and really help ourselves better understand the patients, the treatments, and this terrible pandemic. So thank you all for your time.