Want to be part of advancing cancer detection?

What if you could find out if you had lung cancer through a blood test? Patients at Cape Cod Hospital now have a chance to be part of this promising area of research, with the start of a cooperative study with California-based biomedical company, Freenome Holdings, Inc.

The hospital was picked as a test site for a blood test the company has developed to screen for early-stage lung cancer, according to Elizabeth Sampson, oncology research program manager for Cape Cod Healthcare (CCHC). The contract was finalized in July and study participants are now being enrolled, she said.

Freenome chose the hospital to be part of the study “because we have a robust lung cancer screening program,” said Sampson. As part of Cape Cod Healthcare’s Lung Cancer Screening program, patients who are eligible, due to their smoking history, can receive a low-dose CT scan to screen for undetected lung cancer. Patients are encouraged talk to their primary care doctor or specialist or do an online assessment to see if they qualify for the screening, she said.

“The sponsor (Freenome) was somehow aware of our program and how effective it’s been,” and approached the hospital to be part of the study, she said.

How It Works

The blood test looks for the presence of the DNA of a cancerous tumor, according to the principal investigator on the study for CCHC, medical oncologist Peter Ward, MD.

“The idea of it is to try and detect lung cancer with a blood test, to save the patient having to have multiple CT scans and their exposure to radiation with each scan,” he said. “If we can detect cancer through a blood test, it’s something that eventually may be able to be done in primary care clinics. Where, instead of thinking of cancer screening as you have to go get your colonoscopy and your mammogram and low-dose CT for lung, we will be able to detect all of these cancers through blood tests.”

If lung cancer can eventually be found through a simple blood draw, versus an initial screening CT scan, “how much better for the patient?” said Dr. Ward. Early detection for any type of cancer, generally leads to a better outcome, he added.

Patients who agree to be part of the study are given a one-time blood draw and then undergo a low-dose CT scan within 45 days, said Sampson. Based on their baseline low-dose CT results, the CCHC radiologist will determine how long before the patient needs another CT scan. Generally, it’s done annually, she said.

Any subsequent scans are not a requirement of the new study, but Freenome researchers are interested in any follow-up scans, up to 24 months after the initial one, she said.

Patients who agree to take part in the study are not putting themselves at any risk, should the blood test fail in its goal to detect lung cancer, because they will have the backup CT scan, Sampson said.

The results of study participants’ blood tests will not be shared with them. “(Patients) are just going to follow their normal standard of care with low-dose CT for lung cancer screening,” Sampson said.

Low-Dose Lung Screening

The American Cancer Society screening guidelines recommend that primary care or specialty care providers refer patients who are 50 to 80 years old for yearly screening with low-dose CT if they currently smoke or used to smoke and have a 20-pack-year or more history of smoking.

Pack years are gauged by the number of packs of cigarettes smoked per day times the number of years of smoking. For example, someone who smoked one pack of cigarettes a day for 20 years, or two packs a day for 10 years (and either still smokes or has quit in the past 15 years) would qualify for screening.

Why Enroll?

Patients who enroll in the study have an opportunity to be a part of scientific advancement, said Dr. Ward.

“For a patient who is worried about their risk of lung cancer, they may enroll in this trial because, number one, it’s easy. They’re going for the CT scan anyway and then it’s a simple blood draw. There’s very little risk involved,” he said.

Study participants may also benefit from it down the line if the blood test is successful and comes on the market and is eventually used to detect a lung tumor, he added.

What It Means for CCHC

The Freenome study is part of a growing clinical trials program at CCHC.

“We’ve had a research program for some time, but in order to participate in some drug trials, bigger phase three industry-sponsored trials, you have to show these companies that you have a good research program. They want to partner with a community cancer program that has the ability to just do this well and that leads to success of the trial in some regard. It’s all part of building a research program at a community cancer center,” said Dr. Ward.

The study is a good opportunity for Cape Cod Hospital’s research department, said Dr. Ward. He said he gets about five emails a week about clinical trial opportunities across the country. Many are run through large academic medical centers, and many are starting to also partner with community medical centers.

“I don’t know how (Cape Cod’s) demographics would compare to big cities in terms of smoking rates, but (study sponsors) probably are targeting places where there is greater chance of finding lung cancer,” he said. “Their trial is going to be more successful if they’re enrolling patients that are at great risk for lung cancer.”

Not a Panacea

While blood tests will be a welcome part of cancer screening in the future, they will only provide an initial layer of screening, said Dr. Ward. A blood test for colon cancer, say, will help many people avoid colonoscopies, but those for whom the blood test detects signs of cancer will still need a follow-up colonoscopy to determine where exactly the cancer is, he said.

“If we do these blood tests, we need to be as specific and sensitive as possible because the real downside of have a screening blood test is, say your blood test is positive for colon cancer, and you go in for a colonoscopy and they can’t find a tumor. That’s the thing that scares physicians the most because it can lead to a lot of anxiety on the part of the physician and, obviously, on the part of the patient.”

The Freenome lung cancer study is in its initial phases, according to Dr. Ward, but there are multiple companies trying to develop the same test. “It’s kind of like the race for the prize,” he said. In the end, there will likely be more than one company that succeeds, and physicians will be left to choose between the various tests for their patients, he said.

Freenome will be enrolling study participants for 18 months, after which they will be followed for two years, Sampson said. CCHC may or may not ever know the results of the study. “Sometimes sponsors reach out to let you know and sometimes you see it in a publication and are not notified,” she said.

Sampson, who has been at CCH for two years, worked on the Moderna COVID-19 trial during the initial outbreak, while working at another institution. Seeing how quickly the vaccine was developed and approved gave her hope that drugs and vaccines can be developed faster than in the past. “There’s definitely conferences and discussion groups on ways to make trials quicker”, she said.

Sampson said she loves working on the various studies and clinical trials. “It’s exciting, especially when you know a lot of times really good results come from clinical research. To be part of that is very gratifying.”