Chapter 12: The Evolution of Tumor Registries at MD Anderson

Chapter 12: The Evolution of Tumor Registries at MD Anderson

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In this chapter, Dr. Buzdar explains how tumor registries have evolved at the institution. Originally there were many registries associated with departments, but now there are two. Dr. Buzdar participated in a group to advocate for an institutional bank which was activated on 31 January 2017. He explains that all patients are now asked if they will donate tissue to the bank. He talks about the "clear environment" conditions maintained at the registry and why this is important. Another bank, in existence for two or three years, preserves samples of metastatic disease collected sequentially from a patient as the disease evolves. Dr. Buzdar sketches the controversy around creating these institutional banks. He also talks about the evolution of the methods for analyzing tissues and how they are subject to government regulations when used in research studies. He also stresses that the primary purpose of the banks is patient care: to preserve tissue for use in treating the patient who donated the sample. Dr. Buzdar gives some examples to illustrate how the tissue resources are used. He also talks about the size of tumors and the size of samples preserved.

Identifier

BuzdarA_02_20170216_C12

Publication Date

2-16-2017

Publisher

The Making Cancer History® Voices Oral History Collection, The University of Texas MD Anderson Cancer Center

City

Houston, Texas

Topics Covered

The University of Texas MD Anderson Cancer Center - Building the Institution; Discovery and Success; MD Anderson History; Controversy; Research; Understanding Cancer, the History of Science, Cancer Research; The History of Health Care, Patient Care; Technology and R&D; Institutional Processes; Devices, Drugs, Procedures; Building/Transforming the Institution

Transcript

Aman Buzdar, MD:

There are a lot of tumor registries. Actually, this is another issue in which I am very passionately involved. There are -- in MD Anderson right now, there are more than 26-plus banks, tissue banks. But, a few years ago, when Dr. DePinho came, we wanted to have institutional banks, so we actually started, now there are two banks. One --is every patient who comes over here. This just started, it took me and the administration about close to four years to get this thing done, but it was just activated beginning of this month, actually on the 31st of January. Every patient who comes, we ask them, Can we look at your clinical data? Can we use your residual tissue for future, undefined research? Previously, we were saving these things and asking this, but these tissues were not being saved in what we call a "˜clear environment.' Clear environment means that it has to stay in pathology custody, where they can vouch that this tissue is kept in an appropriate environment. If it is in a clear environment, you can run the tests, say five years from now or two years from now, and say this is a valid test and valid result, and you could make a decision about that patient.

Tacey A. Rosolowski, PhD:

Yeah, it's the integrity of the sample.

Aman Buzdar, MD:

But, the other banks which we have, 25, they are not in a clear environment. So this is the one large clear bank which we have started. Another one is for patients who have, say metastatic disease, or widespread disseminative, any type of cancer. What we ask them is that --we're treating these patients. We want to see that what is unique about their tumor, that they either responded or they didn't respond, and subsequently, if we treat the patient with celontins, they respond, but then they may progress. The question is, What happened? What changed in the tumor biology? So we started another bank, which is called Apollo protocol, which is we're collecting the specimens on patients sequentially, as the disease evolves, to understand why the disease responded or why the disease didn't respond, why the disease which responded became resistant. In some patients, when the patients respond, why did they remain in remission for a long period of time? So these --we are doing these, and getting the genomic information, so this is a huge initiative. Apollo has been active a few years, two or three years, but the other protocol which Dr. George Wilding, our vice president, I mean the vice provost, he is the principal investigator, and we wanted to have it as an institutional resource. This has been started and it is moving forward.

Tacey A. Rosolowski, PhD:

I think I spoke with, I know I spoke with John Mendelsohn, about this sequential sampling of tumors. I mean this was a few years ago. What was that like to implement, because obviously it means additional workflow and activities. What's been involved in making that a reality for the institution?

Aman Buzdar, MD:

The reality is human nature. Always in the beginning, people think that institution wants to dictate everything, because people had their own banks, and then starting an institutional bank. That's why the institutional bank --the one I just described, we just started-- the person who is in charge is the vice provost. He does not have any interest. And this is all patients, different kinds of cancer; lung, breast, ovaries, melanoma, anything, you name it, is there. But, then we're developing appropriate ways, how the tissues will be analyzed, how they will be able to access the tissues. There are appropriate subgroup oversight subcommittees designed to make sure that the process is transparent. But it helps the patient if you save the tissue in a clear environment.

Tacey A. Rosolowski, PhD:

What are some of the issues about processing these samples? I don't know anything about it, so just, you know, what are the discussions about in terms of running the analyses on these?

Aman Buzdar, MD:

The thing is that there is American College of Pathology and also, there is federal regulations. Any tissue which is removed from the person has to go to pathology, and it has to stay in a pathology controlled environment. If a tissue is removed and you take part of that tissue before it goes to pathology, for research purposes, and you run some tests on that in say, Dr. Jones's lab, you can't use those test results because it is not an appropriately accredited laboratory to carry out that research. Yes, you could publish the data for research purposes, but you can't make the decision for that patient whose specimen you are looking at.

Tacey A. Rosolowski, PhD:

Interesting.

Aman Buzdar, MD:

This is the law of the land.

Tacey A. Rosolowski, PhD:

Just so I'm clear, you can't use that information to treat the patient if the study has not been conducted in an accredited environment.

Aman Buzdar, MD:

In an accredited pathology and clear environment.

Tacey A. Rosolowski, PhD:

Wow, okay. So obviously, you know, there's an interesting network assuring the integrity of the sample, the safety of the patient, the integrity of the research protocol, it's all connected.

Aman Buzdar, MD:

And then the challenge was to make sure that these things are saved in an appropriate environment, that if a patient has a problem, say next week or ten years from now, that we are able to pull the tissue out and do as the technology evolves, the tests on a tissue which is in a clear custody.

Tacey A. Rosolowski, PhD:

So, the benefit for the institution is you not only can go back and essentially do more in-depth research on an individual, the natural history of an individual's cancer, but then obviously, you can use all that information in terms of more population based studies, on how cancer behaves in general. Is that the logic, that it can be used as a more general resource for research?

Aman Buzdar, MD:

The number one aim is that you need to have the tissues saved in a place where, if the patient has a challenge of cancer recurring, you are able to run tests on that specimen if new tests come up, and the tissue is appropriately saved in a clear environment.

Tacey A. Rosolowski, PhD:

Okay, so really the first benefit is the individual patient.

Aman Buzdar, MD:

First is for the patient. It is firs. The foremost is always the patient. Second is that let's say that six months or six days from now, somebody comes up, Oh, I have this test which I have done, in a non-clear setting it tells this thing can happen to this. You can then, if you have 2,000 or 20,000 specimens, you can identify and run this test in a clear environment, to see if it stands on its two feet or not. Then it is a test which is run in an accredited lab, under clear environment. You run any test "“if there is known positive tumors which are showing-- when you run the test, positives always turn out positives. If there are specimens which are negative for that marker, they should be always negative, and then in-between is the tumor of the patient, whether it goes this way or this way.

Tacey A. Rosolowski, PhD:

Oh, I see, okay.

Aman Buzdar, MD:

Whereas when you are doing the research, you're just running the test and interpreting the test.

Tacey A. Rosolowski, PhD:

Interesting, okay, so you basically have a standard to run.

Aman Buzdar, MD:

Where there is a control, concurrent positive, concurrent negative control, also running in these patients.

Tacey A. Rosolowski, PhD:

Because I was going to ask you, what really is involved in a clear environment. It's not simply storage.

Aman Buzdar, MD:

No, it's not, like that closet [gesturing] doesn't have-- there is a lot of checks and balances. These tests in the regions, and everything which is utilized, they meet standards which are set by the American College of Pathology.

Tacey A. Rosolowski, PhD:

Interesting. What kind of training does somebody need to maintain a clear environment? Is it special?

Aman Buzdar, MD:

A whole department. A whole Department of Pathology gets accredited. There is a license.

Tacey A. Rosolowski, PhD:

Okay, wow, that's pretty amazing. So this has been in existence for two or three years at this point.

Aman Buzdar, MD:

The residual specimens, two or three years, but the hospital has been clear certified for a long time.

Tacey A. Rosolowski, PhD:

Oh, okay, yeah, yeah. So, how has the existence of this resource changed the way that physicians or researchers practice? Is it being called on regularly? Do people still need education about it, what's been going on?

Aman Buzdar, MD:

We make sure that everybody understands how to access the tissue. What are the mechanisms? The tissues are patient's property and the institution property, but if you have a research, it has to be reviewed according to the regulations. Again, my office is responsible for those regulations. If somebody wants to run ten specimens --they want to run, of human X tumor, A, B, C-- they have to write a research protocol. It has to be reviewed by the institutional review board, it has to be approved before they release that specimen. In a number of cases it depends. If it is an archival tissue, the specimen is already there, IRB, they have the consent, but if it is a new person you are going to contact, it will require that participants understand and voluntarily agrees that you could look at their tissues for research purposes. So there are a lot of checks and balances which have to be done.

Tacey A. Rosolowski, PhD:

Right. Just, I mean there is a really basic question. How big are these samples, you know how much tissue is actually taken?

Aman Buzdar, MD:

Sometimes, tumors may be large, but as our early detections effort increases -- I can give you an example. Breast cancer, which we used to see in the '70s and the '60s, used to be very large. Now these cancers are detected by mammograms, and a number of times, you may not even feel anything when even you are looking at the patient, after looking at the mammogram. So the volume of tumors is very variable. Sometimes it may be generous volume, sometimes it may be just a few-millimeters tumor. So you have to be very cognizant that you don't want to utilize the tissue for totally research out of your own curiosity, that you need to -- there is a requirement that you have to save these tissues for X period of time, which is a minimum of ten years, for patient care.

Tacey A. Rosolowski, PhD:

And so there are times when you actually have, in the tissue bank, an entire tumor that's been taken, or do you only take part of it?

Aman Buzdar, MD:

No. We try to make sure that there is pathology on that. Our Pathology Department, Dr. Stan Hamilton and his team's responsibility is to make sure to not deplete the whole specimen.

Tacey A. Rosolowski, PhD:

That's really amazing. Is this a usual practice in cancer centers at this point?

Aman Buzdar, MD:

I think it's becoming increasingly, because this is --as technology is evolving, markers are evolving, assays are evolving, that we're starting to understand, what are the mechanisms of disease resistance, what is the mechanism of even the disease? I'll give you an example, say lung cancer. Lung cancer, a few years ago, there were very few things which you could do, and the majority of these patients unfortunately died, unless you did surgery and you detected the cancer very early. But now, there are a whole bunch of specific targets which have been identified on lung cancer, and there are whole, specific --you see the TV ads every day, sitting at home, and those are real, they are not somebody's imagination. "ƒ

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