The Shine On Project
Status: Ongoing but enrollment closed
Purpose of study
Note, enrollment is on hold due to enrollment goals being met.
The Shine On Study was conceived to reduce the mortality and the suffering caused by canine hemangiosarcoma. Shine On consists of three phases. In Phase 1, we developed and refined a blood test to diagnose hemangiosarcoma. In Phase 2, we determined the utility of this test to determine if the disease had returned in a dog that was being treated for hemangiosarcoma. And in Phase 3, we established the utility of the test to diagnose hemangiosarcoma in the earliest stages, so that we could intervene to prevent the disease in otherwise healthy dogs. In this case, prevention would be achieved using the drug eBAT to kill the cells that create and maintain the tumor and to make the environment inhospitable to tumor growth.
The first question we asked was, “Does the blood test accurately detect the presence of hemangiosarcoma in dogs?” The answer is an unqualified, “Yes.” Our results show that the test accurately identifies dogs in which hemangiosarcoma is present about 90% of the time.
The second question we asked was, “Can the blood test predict when treatment fails, and the disease comes back in a dog that is undergoing treatment?” So far, our results suggest the answer to this question is also, “Yes.” We expect to be able to confirm this answer through ongoing analysis of the available data.
The third question we asked was, “Can the blood test be used to detect the presence of hemangiosarcoma at the earliest stages in otherwise healthy dogs?” In other words, could we identify dogs at high risk of hemangiosarcoma that would benefit from prevention? Again, our results to date suggest that the answer to this question is, “Yes.”
We will continue to follow the 209 dogs tested as part of Shine On Phase-3 to establish the reliability of the test results, and how often the test would need to be repeated to maximize its utility. But so far, we estimate that the likelihood of a dog that tests “negative” to develop hemangiosarcoma over the subsequent 6-month period is less than 1%, whereas more than 90% of dogs with a “positive” test require further evaluation for the presence of disease, and those where hemangiosarcoma is not identifiable would be candidates for prevention.
The final question we asked was, “Is eBAT safe, and is it effective for hemangiosarcoma prevention?” We can say definitively that eBAT is remarkably safe. We understand its potential side effects and they are readily manageable. eBAT is also effective at prevention of hemangiosarcoma in laboratory models. The ongoing follow up of dogs at risk that did - or did not - receive eBAT prevention will allow us to confirm the utility eBAT as prevention for hemangiosarcoma.
Updates of these results have been disseminated throughout the project to the professional and lay communities alike, at scientific and veterinary meetings, at health seminars held during several National Breed Specialties, and at the AKC Parent Club Meeting in 2019. We will continue to disseminate results and updates through these venues, as well as through scientific, peer reviewed publications as we complete follow-up for the project.
Phase 1 was designed to refine the hemangiosarcoma diagnostic blood test. We collected blood samples from dogs in the four categories below, all from cases which were seen at the Veterinary Medical Center only.
Dogs with confirmed hemangiosarcoma. This group included dogs that had a pathologically confirmed diagnosis of hemangiosarcoma from any anatomical site, at any stage of disease, of any pathological grade, and dogs could be of any breed, age and sex as long as samples were obtained prior to removal of gross tumor burden (primary or recurrent). Dogs in this group were be re-tested every 60 days in Phase 2.
Dogs with confirmed non-neoplastic (non-cancerous) splenic lesions. This group included dogs that had a pathologically confirmed diagnosis of splenic nodular hyperplasia and/or splenic hematoma and/or splenic hemangioma. The disease could be at any stage with dogs of any breed, age and sex as long as samples were obtained prior to splenectomy. Dogs in this group were re-tested at 6-month intervals in Phase 2. We expected to recruit 25 dogs into this group.
Dogs with any confirmed cancer other than hemangiosarcoma. This group included dogs that had a pathologically confirmed diagnosis of cancer other than hemangiosarcoma, specifically malignant lymphoma (any subtype), osteosarcoma, soft tissue sarcoma, or carcinoma. The cancer could be in any anatomical site, at any stage, have any pathological grade, and dogs could be of any breed, age and sex as long as samples are obtained prior to removal of gross tumor burden (primary or recurrent). Dogs in this group were re-tested at 6-month intervals in Phase 2. We expected to recruit at least 25 dogs, and potentially up to 75 dogs into this group.
Healthy young dogs. This group included young dogs (under four years of age) with no evidence of any disease recruited from our general practice well-health program and from the hospital staff pet population. We expected to recruit at least 25 dogs into this group.
Phase 2 was designed to determine the ability of the diagnostic blood test to predict relapse in dogs with hemangiosarcoma that are undergoing treatment. This phase was limited to dogs recruited as part of Phase 1, and will be completed at the end of year 3 by retesting dogs in the groups as described above.
Phase 3 is studying the hemangiosarcoma detection test in early detection and prevention of hemangiosarcoma in purebred Golden Retrievers, Portuguese Water Dogs and Boxers.
Phase 3 was to determine if a test looking for specific cells in the blood could be used to detect hemangiosarcoma in its earliest stages, before a tumor has formed.
- Must be an AKC-registered or pedigreed Golden Retriever, Portuguese Water Dog, or Boxer.
- Dogs must be at least 6 years old and in good general health.
- Owners must agree to submit blood samples for re-testing according to the study guidelines.
- Dog/Owner must live in the contiguous 48 states.
Dogs that have positive test results, and that do not have a detectable tumor, will have the option to receive the experimental drug, eBAT, to determine the drug's potential to prevent progression of disease.
Treatment with eBAT will be done exclusively at the Veterinary Medical Center, University of Minnesota in St. Paul, MN.
NOTE: The Shine On study is not intended as a diagnostic for disease. It is an experiment to determine whether the blood test can be used as a tool for early detection of hemangiosarcoma. At this point, we do not know if a negative test result means the dog does not have, or will never get, hemangiosarcoma. We also do not know if a positive test result means that a dog will definitely get hemangiosarcoma. The study is designed to answer some of these questions.