For 30 years, Marla Mills-Wilson worked behind the scenes of clinical trials, helping biotechnology and pharmaceutical companies operationalize research across a range of cancers.
Then, at 54, she found herself on the other side.
“When you’re in that chair as a patient, I felt like my life kind of flashed before me,” Mills-Wilson said.
Last year, the Youngsville mother of two was diagnosed with pancreatic cancer. It is the same disease that her mother died from at 73 years old.
“Not only did my mother pass away from pancreatic, my father is a stage four prostate cancer survivor,” she said. “Both of my grandmothers passed of cancer.”
When asked what her first thought was after learning of her diagnosis, Mills-Wilson replied, “Am I going to end up like my mother?”
She continued, “It’s hard. I remember being in the dark and feeling that even though it’s sunny outside, I was so dark on the inside. I felt like I couldn’t think right.”
Mills-Wilson made her family history known to her doctors at every appointment, and made sure she kept up with regular physicals, saw a gastroenterologist and underwent genetic testing.
Still, it was not screening that led doctors to her pancreatic cancer. It was a subtle symptom: amber-colored urine.
At first, Mills-Wilson wondered whether she was dehydrated or had a urinary tract infection. A visit to urgent care instead raised concerns about a low heart rate, and ultimately sent her to the emergency room.
Mills-Wilson was diagnosed with stage two, locally advanced pancreatic cancer. She said the tumor was wrapped around blood vessels, initially preventing her from undergoing surgery.
As “patient one” in a separate UNC clinical trial, Mills-Wilson received a drug being studied in patients with pancreatic cancer as part of her treatment. She had a near-total treatment response, and after six months of chemotherapy, her tumor was no longer wrapped around the vessels and she underwent Whipple surgery.
Now, after participating in a clinical trial as a cancer patient herself, Mills-Wilson is encouraging other North Carolinians to consider taking part in research that could help change how cancers like hers are detected.
UNC Lineberger Comprehensive Cancer Center is seeking 2,000 North Carolina participants for the Vanguard Study, a national clinical trial evaluating blood-based tests designed to detect signals from multiple types of cancer at once.
Researchers hope the study will help answer a much bigger question: Could a routine blood draw eventually help doctors find cancers that currently have no standard screening test, before symptoms appear?
What is the Vanguard Study?
Dr. Carrie Lee, a thoracic medical oncologist and chief medical officer for clinical research at UNC Lineberger Comprehensive Cancer Center, is one of the co-principal investigators of the NCI-sponsored Vanguard Study.
Lee explained that evidence-based screening guidelines currently exist for four major types of cancer: lung, breast, colorectal and cervical cancer. Several other deadly forms — including pancreatic, ovarian and stomach cancer — do not have routine screening methods.
“The goal here is really to evaluate novel mechanisms to screen for cancer,” Lee said.
The Vanguard Study is evaluating a newer screening technology known as multi-cancer detection assays, or MCDs. Unlike traditional screening tests that look for one type of cancer, the blood-based tests are designed to look for signals from multiple cancers at the same time.
“What’s really cool about them is that they are what we call blood-based,” Lee said. “They are a tube of blood that can be very easily drawn. That is then used to screen for multiple cancers at once.”
The Vanguard Study is evaluating two different multi-cancer detection assays. Participants are randomly assigned to one of three groups: two use different MCD assays and the third serves as a control group.
For participants assigned to one of the groups receiving an MCD assay, Lee said any positive cancer signal will be reported back to the participant and their doctor so they can undergo additional testing.
Researchers will also track what happens after a test identifies a possible cancer signal.
“What happens to a patient who has a positive multi-cancer detection assay? How often are patients actually diagnosed with cancer?” Lee said.
UNC Lineberger is one of nine hubs across the country that make up the new National Cancer Institute-funded Cancer Screening Research Network. Each hub is working to enroll about 2,000 participants, bringing the Vanguard pilot study to roughly 18,000 to 20,000 participants nationwide.“There may be a time in the future that cancer screening is perhaps less about mammograms and colonoscopies, and more about having a blood test,” Lee said. “For some patients, that’s really attractive because some of those tests and procedures can be associated with time off work and things like that. Finding ways to screen for multiple cancers at one time and to make it less onerous for patients is really the goal.”
For now, however, Lee cautions that it remains a possibility researchers are studying and not established medical practice. She said people should not yet stop getting their recommended screening exams, including Pap smears, CT scans, mammograms and colonoscopies.
“It’s not ready for primetime yet,” Lee said. “There’s lots of promise, but we don’t want to overhype.”
There are currently no FDA-approved multi-cancer detection assays, Lee said, although some are commercially available for roughly $700 to $1,000 out of pocket.
Lee said results from the Vanguard pilot study will likely inform a much larger clinical trial, potentially involving around 200,000 people.
Who can participate in North Carolina?
UNC researchers are seeking adults between 45 and 75 years old who have not had a cancer diagnosis within the past five years.
The North Carolina hub has already enrolled more than 600 people toward its goal of 2,000 and expects enrollment to remain open for at least another year.
Researchers are specifically trying to recruit participants who reflect the diversity of North Carolina, including people outside the Triangle and across racial and socioeconomic backgrounds.
“We want to make sure that our results that we learn from the study are applicable to the entire population,” Lee said.
To make participation more accessible, parts of the study can be completed remotely and participants do not necessarily have to travel to Chapel Hill.
Blood collection is required at the beginning of the study and again one year later, with collection sites available in Chapel Hill, Hillsborough and at UNC Health Southeastern in Lumberton.
Those interested can contact the Vanguard Study team directly:
Email: LCCC_VanguardStudy@med.unc.eduPhone: (919) 843-4863
A new future of care
After her clinical trial and subsequent Whipple surgery, Mills-Wilson said she is doing well and returns to UNC every three months for scans and blood work.
Now, she hopes sharing her experience can encourage others to participate in the kind of research she has spent much of her career helping conduct.
“The Vanguard clinical trial is so important. No one wants to be diagnosed with cancer,” she said. “Early detection is everything.”
She also stressed the importance of including people from different backgrounds in clinical research.
“The more people we have to participate in clinical trials of all ethnicities, walks of life, the better it is for cancer,” she said.
For those who may qualify for Vanguard, Mills-Wilson has a direct message.
“It is easy to go about our daily lives, and not understand the impact,” she said. “Some people may not understand how cancer may impact families, but I want to impress upon everyone the importance of clinical trial participation.”
The mother added, “We really need the community to participate in this clinical trial, to reach out to UNC to understand if they are eligible to participate. We need the community’s participation.”
For Mills-Wilson, the question is no longer theoretical.
Her mother was diagnosed with stage four pancreatic cancer and died within months. She herself had been health-conscious and felt well before subtle changes led to her same diagnosis.
Mills-Wilson now thinks about what earlier detection could mean for her 21-year-old son and 15-year-old daughter.
“Who knows what this could entail or lead to? It could potentially lead my daughter and son to be able to have these at an earlier age, as opposed to waiting or finding out later,” Mills-Wilson said.
Lee said that is the kind of future researchers hope studies like Vanguard can help determine is possible.
“Maybe there’ll be a way to help patients like Marla to understand that they have cancer sooner before it has spread or really become a threat to their life,” Lee said.
Mills-Wilson hopes North Carolinians who qualify will consider participating, both for what they could potentially learn and what their participation could mean for future patients.