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University of Iowa Hospitals seeking participants for new clinical trial for certain colon cancer patients

Applications should be opening for the clinical trial on March 20th.

IOWA CITY, Iowa — In 2023, the American Cancer Society expects 106,970 people to be diagnosed with colorectal cancer, or colon cancer. The ACS also says that 52,550 people will die from colon cancer this year. 

The University of Iowa Hospitals is aiming to change the way colon cancer is treated with a new clinical trial, which will use immunotherapy. The clinical trial should start accepting applications on Monday, March 20, 2023.

News 8's David Bohlman spoke with University of Iowa hospital's Saima Sharif, MD on the new immunotherapy. 

Bohlman: Tell us how this clinical trial came about.

Sharif: So the background of this clinical trial is [that] I see a lot of colon cancer patients, that is my area of expertise at the university. And I saw that patients with certain mutations were doing very well on a certain type of treatment called immunotherapy. 

And usually, for early-stage colon cancer, another standard of treatment is surgical resection, when these patients eventually did go for surgical resection, there weren't any cancer cells left. 

So that got me thinking about doing and studying a clinical study in a clinical trial, and [finding out if] these patients need surgery or not. And this is the background and the basis of my clinical trial that I am doing at the university.

Bohlman: Are you still looking for people to be a part of this clinical trial?

Sharif: We have not started enrolling on this trial yet. As I mentioned, the standard of treatment is surgical resection. This protocol has been IRB approved and is ready to enroll patients this coming Monday. It will be a 25-patient trial. We have not started enrolling yet we needed IRB approval, which is required and FDA approval to start running this trial. And we are hoping to start enrollment on Monday.

Bohlman: Why is something like this clinical trial important?

Sharif: So after breast, prostate and lung cancer, this is the most common cancer in the whole world, including the United States, including Iowa. So why this is important? When you look at colon cancer, given that this is very common, about two-thirds of patients will be diagnosed with early stage. 

So my trial is in early-stage cancers, one in five patients will who come in through the door will have this mutation. So that's a significant number of patients. And when you do surgical resection for these patients, they have to deal with lifelong bowel issues, which they adjust to because they know they've had the cancer surgery. 

But do they really need to do that? Do they need to really undergo surgical resection is the question. And then if this trial is successful, some other data that is coming out from other institutions will be very helpful in changing the treatment paradigm, which is the state changing the standard treatment of these patients undergoing surgical resection. 

This is why I think this study is very, very important because there is a significant amount of patients who can prevent or avoid surgical resection.

Bohlman: Who should speak to their doctor about being a part of this clinical trial?

Sharif: So there's a specific mutation that we're looking for. So what patients who are listening should be talking to their doctors, about is does their tumor have the marker or the mutation that would make them eligible for immunotherapy. 

I know it's a very technical term which is MSI high or deficient MMR. But as long as patients know to ask their doctors to do I have the immunotherapy marker before their resection because it's usually we do not see patients as an oncologist before their resection. I see them after they've been resected. 

So when their gastroenterologist does their or their surgeon does their screening colonoscopy, and they find that they have a new diagnosis of colon cancer, it has not spread to any other parts outside the colon, like the liver or lung, they should be asking this question. If my tumor has this one marker for immunotherapy, then they are the patient to be referred to the University of Iowa to be part of this clinical trial.

Bohlman: How does immunotherapy differ from the traditional surgery?

Sharif: Immunotherapy is a new class of medications, which stimulates a person's own immune system. So whenever we have an infection, there's you know, there are cells in our body that recognize it as foreign and it attacks it and the infection goes away with a little bit of help of antibiotics, sometimes we don't even need them. 

So this is what immunotherapy does. Cancer has a way of outsmarting the immune system and does not recognize that it is foreign. Therefore, the immune system does not attack it. 

So by giving immunotherapy, we remove the brakes that the cancer puts on our immune system in recognizing it as foreign and making our immune system, or our fighter T cells as you can call them, recognize that cancer cells are abnormal. And they unleash a mechanism to try to kill these cancer cells. So this is a very smart way of attacking cancer cells. And in short, it is stimulating in patients or cancer patient's immune system to attack the cancer cells.

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