Project Summary
Like the National Cancer Institute and the Russian Basic Research Foundation (RFBR), our goal is to eradicate
cancer. One path to this goal is to detect cancer early, both primary and recurrent. For example, detection and
treatment of Stage I breast cancer has a nearly 100% five-year survival rate. Besides early detection, it will
become increasingly important to be able to specify the type of cancer for more precision treatments. Towards
these goals the Biodesign Institute, Center for Innovations in Medicine in the US (CIM) and the Russian American
Anti-Cancer Center (RAACC, http://rustec.asu.edu/raacc.shtml) in Russia propose two aims. We will determine
if the immunosignature diagnostic (IMS) technology can distinguish four different subtypes of breast
cancer (luminal A, luminal B, HER2 enriched and basal). The second aim will be to determine if the IMS
technology can detect recurrence of breast cancer using samples collected over time from the same
person. Samples will be collected at the Altai Regional Cancer Center in Barnaul, Russia and at Duke University
in the US. This will allow us to determine not only whether there are uniform immune signatures for each cancer
and recurrence, but also whether the signatures are the same at both sites. In Aim 1, 50 samples of each subtype
at each location and 100 controls will be used in a training set. The accuracy will be determined in an
independent and blinded test set of samples. US samples will be sent to Russia to estimate the inter-site
variation. In Aim 2, IMS will be applied to serial sample collections from women after treatment to determine the
feasibility of applying IMS to detect recurrence. The IMS technology is very promising relative to these
applications. It is based on the assessment of the antibody complexity in a single drop of blood. This is done
on specially designed, mass-produced peptide microarrays. The peptides are chosen from random sequence
space and specifically designed to maximally represent chemical diversity and thereby optimize antibody
discrimination. The chips are disease agnostic and can be used for any disease, with multiple diagnoses
possible for a single person. The blood samples can be sent as dried blood spots through regular mail, facilitating
compliance and regular monitoring. The IMS technology was invented at CIM and it has facilities for the
production of IMS microarrays and the analysis. CIM collaborated with the Altai State University and the Altai
Regional Cancer Center to establish the RAACC in 2013. The RAACC has purchased the equipment and CIM-
trained personnel to perform IMS. CIM has spun off a company, HealthTell, Inc, to commercialize IMS
diagnostics. CIM and RAACC will work with HealthTell to commercialize the two types of diagnostics tested
here if they are promising.