GRAND FORKS — For Ashlee Dagoberg, manager of Altru's research program, the connection to the company’s biorepository study is somewhat personal.
“My mother had breast cancer,” Dagoberg said. “She went and had a genetic test to see if she had the BRCA 1 and 2 gene, and she didn’t.”
Altru Health System is using the Altru Cancer Center in Grand Forks to collect specimen samples for research, which is known as a biorepository study. In these studies, researchers scavenge the specimen for biomarkers, which are genes, proteins and other substances providing information about cancer. Its biorepository studies are currently active and open to enrollment.
Dagoberg used her mother as an example to explain how biomarkers work and what they can tell doctors about a person’s genetic prognostics. The BRCA 1 and 2 genes are the most commonly affected in hereditary breast and ovarian cancer patients. According to the CDC, about 3% of breast cancers and 10% of ovarian cancers are caused by inherited mutations in the BRCA1 and BRCA2 genes.
“That was a biomarker that said, ‘OK, your family isn't at any increased risk for breast cancer, even though you had it,’ because they took a test to see if she had that biomarker, the BRCA 1 and 2 gene in, in her system, and didn’t find it,” Dagoberg said.
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The timeline for the biorepository study is five years. Dagoberg said as Altru begins to accrue patients, they could be asked to come back and provide more samples and additional data throughout the timeline, however it would be unlikely.
So, what makes someone a good candidate for Altru’s biorepository studies? Altru is focused on breast and colorectal cancer for the study due to the volume of patients diagnosed each year with those conditions. Each year, Altru’s Cancer Center gets anywhere from 850 to 900 new patients, which it calls its “analytical caseload.” Breast cancer patients make up about 15% to 20% of that caseload each year, and colon cancer is around 6% to 8% of it. Dagoberg said Altru has seen colon cancer pop up more in recent years.
“When I started getting into the oncology research here at Altru and found out that cancer was really the second leading cause of death in the state of North Dakota, it really geared me to focus on our oncology research portfolio and what we could start adding, because there's such a high incidence in North Dakota,” Dagoberg said.
Dagoberg said biorepository studies have had a presence in research for the past five to 10 years, but their usage has increased recently. She said they are popular because they’re designed for the purpose of creating quality biospecimens.
“If you think of a repository, that's like a centralized storage area,” Dagoberg said. “And so these repository studies, they are basically databases, registries and tissue banks all for research purposes.”
When a patient agrees to enter into a biorepository research study, researchers collect a biological specimen, usually blood, tissue, urine, sputum, or bone marrow from donors and then takes clinical data and molecular profiling information, which is sent over to the storage areas of the sponsors it is working with, usually biotech or pharmaceutical companies. However, Altru is only taking blood for its biorepository study.
“The (sponsor) that we're working with for the (breast cancer) study, they're looking for 3,000 participants for this,” Dagoberg said. “This is a multi-site trial, so we're not going to have 3,000 Altru patients donating blood for this biorepository protocol, but we can actively participate until that sponsor meets their enrollment numbers.”
Dagoberg said Altru will always send information and an informed consent form telling the patient exactly what happens during the study and what to expect from it, including specifying the study is not aiming to treat patients directly for their cancer but to instead analyze it for future diagnostic use.
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“I think that we find a lot of people that have had family members that have had cancer or have known someone, or had friends (with it),” Dagoberg said. “This hits close to home, because this is a way that you can do something that can identify the best therapeutic approach for certain cancers or can help with different treatment combinations so people have a great overall survival rate.”