Research update from Dr. Modiano for Shine-On Hemangiosarcoma project looking into treatment of this disease.
During the 36 months that the project has been active, we have made substantial progress toward our objectives, and from the experience we have gained, we have made some adjustments to the experimental set-up. The project goals have not been modified. Specifically:
1. As of February 28, 2019, we had evaluated the parameters of the detection test on 90 dogs that had diagnoses of hemangiosarcoma, non-malignant spleen masses, other tumors, or no apparent illness (Shine On phase 1).
2. We updated and refined the criteria and the algorithms to assign dogs into one of four risk categories:
a. Apparently healthy;
b. Benign splenic lesions or benign blood vessel pathology (this category includes production of new blood cells in an organ other than the bone marrow and nodules in the spleen associated with immune reactions and/or blood clots);
c. Non-hemangiosarcoma cancers; and
3. We opened Shine On phase-3 on January 2, 2018. As of February 28, 2019, we had enrolled 142 healthy dogs (Golden Retrievers, Boxers, and Portuguese Water Dogs).
We have concluded that the best way to establish the performance of the test in apparently healthy dogs (early detection) is to follow these dogs through an extended period of time to determine if they eventually develop the disease. To our knowledge, this is the first time this type of bold experiment will have been done in dogs.
We have added new parameters to the assay to further improve its potential performance.
Managing Shine On holistically, and evaluating all the data in aggregate, will provide more robust data than if we were to parcel out the results by phase. This was not something we could have easily predicted in foresight, but it is clear in hindsight. In other words, since interim analyses are fraught with risk, we have decided to avoid strong conclusions from incomplete data. We will, of course, conduct a complete and thorough analysis of all the data once all the samples are collected and processed through the assays, and the results, whether positive or negative, will be reported to the AKC CHF and through them to the foundations that have supported the study. We also intend to publish the data in the peer reviewed literature. Regardless of the final result, there is significant innovation in this trial that will be of interest to the biomedical and translational communities. We are excited to document that large-scale trials for early cancer detection are feasible in companion dogs.