Shine On Continuation (Phase 3)
For questions about the Shine On project:
Jaime Modiano, VMD, PhD
[email protected]
Eligible owners will be contacted by the study team. Please do not email to request to enroll.
Study title
Strategic Prevention of Canine Hemangiosarcoma: Lifetime Follow-Up
Purpose of study
New participants are being enrolled by invitation only from among those who previously signed up for Shine On Phase 3.
In order to participate, you must have received an invitation and a code for enrollment.
The goal of the Shine On Project is to develop a simple and reliable test that can predict the risk of dogs to develop hemangiosarcoma or other life-threatening cancers, and to combine that with an intervention that alters that risk, effectively preventing, or at least delaying the onset of cancer. The preliminary results of the Shine On Project are extremely encouraging. We have determined the SOS test has the potential to identify dogs at risk for hemangiosarcoma and other life-threatening cancers 2 to 4 years before a tumor appears and clinical signs are noticeable. A critically important aspect of our work is that we are making the information “actionable” by evaluating whether the drug eBAT can change the course of cancer risk. eBAT is effective as a component of the treatment of hemangiosarcoma and other tumors. Among the unique features of this drug are its remarkable safety and its modes of action, as it works not only by killing malignant tumor cells, but also by creating an inhospitable environment that makes it difficult for tumors to grow. This Shine On Continuation phase is specifically for testing the efficacy of eBAT in prevention.
See more about the Shine On Project.
Eligibility criteria
- Invitation only - Owners will have received a letter from the Modiano Lab
- Must be an AKC-registered or pedigreed Golden Retriever, Portuguese Water Dog, or Boxer
- Dogs must be between 6 and 10 years old
- Dogs must be in good general health (no evidence of cancer, undiagnosed lumps and bumps, or other serious chronic diseases)
- Owners must agree to submit blood samples for re-testing according to the study guidelines
- Dog/Owner must live in the contiguous 48 states
Procedures
Owners will send blood samples from their enrolled dogs, collected at their home veterinary clinics, for testing at defined intervals.
Based upon the results of this testing, dogs that are assigned to the high-risk group for cancer will have the option to receive eBAT prevention at the Veterinary Medical Center, University of Minnesota in St. Paul, MN. In order to qualify for prevention, dogs will need to have additional blood tests and imaging tests at the VMC to ensure a tumor is not already present.
Prevention includes three treatments with eBAT done over a 5-day period, so the process requires participants to be at the VMC several times during a 1-week period. The screening tests and the treatment can only be done at the VMC, so dogs whose owners are willing and able to be in St. Paul or the surrounding area for at least 7-8 days, if eligible, will be given preference for enrollment.
Costs
The study will cover all the costs associated with shipping the blood samples for testing, screening at the VMC, and eBAT administration (for eligible dogs), and it will also provide housing assistance.
Study update
The Shine On Study was conceived to reduce the mortality and the suffering caused by canine hemangiosarcoma. Shine On consisted 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.