Study Title:
Screening Efficacy of At-Risk Canines undergoing Healthy Routine Examination: Using Cancer Dx to Screen for Lymphoma
Study Number: CMO500149
Dear Pet Owner:
You have been invited to enter your dog into a research study to evaluate the utility of the new IDEXX Cancer Dx test for early cancer detection. Please read this form carefully, and feel free to ask any questions you might have.
The purpose of the study is to determine how the IDEXX Cancer Dx test can be used in dogs for early detection of a type of cancer called lymphoma. The test detects markers in the blood that can indicate lymphoma is present. Early detection of cancers can provide more options and opportunities for treatment for dogs and their families. This study will also help to determine the best recommendations for use of the test during wellness visits.
If you agree to participate in this study, your dog will have his/her wellness visit according to your usual veterinary clinic protocols. To be eligible to participate, your dog must be having a bloodwork profile sent to the IDEXX Reference Laboratory to check overall health (CBC and chemistry profile). You will be responsible for the cost of the exam and the general bloodwork profile.
As part of the study, this blood sample will also be used for the Cancer Dx blood test, which will be done at no charge to you. Your veterinarian will also fill out a short study form to provide information about your dog’s age, sex, breed, current health conditions, and medications.
Your veterinarian will receive the results of the bloodwork profile and Cancer Dx test and will be able to use those results for your dog’s care. If the Cancer Dx test is negative, no further workup is recommended as part of the study. Your dog should continue to be monitored for any clinical signs of illness as usual and seek veterinary care if you have any concerns.
If the Cancer Dx test is positive, your veterinarian will discuss with you some recommendations for next steps for a diagnostic evaluation to look for cancer in your dog. A positive test does not mean that your dog definitely has cancer but increases suspicion that your dog could have lymphoma. Your veterinarian may recommend fine needle aspirates (using a small needle to collect cells) of your dog’s lymph nodes for cytology (analysis under a microscope), x-rays of the chest, and an ultrasound of the abdomen.
The study will cover up to $1000 for study-approved diagnostic tests, which include those listed above. Depending on these results, other tests may be recommended as well. The study will pay your veterinary clinic (or another veterinary clinic if you have diagnostic tests performed elsewhere) directly. Any costs over $1000 will be your responsibility.
To be eligible for the financial support, the diagnostic testing process must begin within 2 months of the enrollment visit. Financial support eligibility will expire 3 months after the enrollment visit. Any testing performed following this date will not be eligible for financial support.
Your dog may benefit from the study by having a Cancer Dx test that may identify lymphoma in its early stages. This will provide you with the opportunity to decide on the best next steps for your dog. Your dog’s participation will also help us to better understand how best to use Cancer Dx as an early detection test, which will benefit future dogs as well.
Obtaining a blood sample from your pet is a standard medical procedure performed by your veterinarian and causes minimal pain or discomfort to your pet, and risks of adverse events are low. However, your pet may experience unexpected side-effects which are typically mild. Adverse effects may include bruising or bleeding which should resolve without specific treatment.
The tests that may be performed if your dog has a positive Cancer Dx test are also standard medical procedures. X-rays and ultrasound should cause no pain or discomfort. It is possible your dog may need to be sedated for these procedures. If this is the case, your veterinarian will discuss the risks of the sedatives they choose with you. Fine needle aspirates of the lymph nodes are typically done without sedation and cause only very mild discomfort. Risks are rare but could include bleeding or bruising that should resolve without specific treatment.
There is a chance that your dog could have a positive CancerDx test, but lymphoma is not detected after the diagnostic workup. In this case, you and your veterinarian can monitor your dog closely for the development of any clinical signs or enlargement of lymph nodes.
There is also a chance that your dog could have a negative CancerDx test but develop lymphoma in the future. A negative CancerDx test means that lymphoma is unlikely to be present, but it does not mean that lymphoma or any other type of cancer cannot develop in the future.
A follow-up survey will be available to your veterinarian 3 and 6 months after the CancerDx test is performed to gather information on any medical issues that your dog has had. Your veterinarian may contact you for a health update on your dog at these time points.
Your participation in this study is completely voluntary, and you can withdraw your pet from the study at any time without jeopardizing your relationship with your veterinarian. If you do not wish to participate, you do not have to provide any reason for your decision, nor will you lose the benefit of any veterinary care your animal is receiving.
If you withdraw your animal from the research project, any data collected about him/her during their time in the study will be retained for analysis. You agree that IDEXX Laboratories shall own all rights in the samples, and you waive any right of inspection or approval with regard to any use of the samples.
Your pet’s blood sample will be identified by their name and unique number only. Any contact between you and IDEXX Laboratories will be through your veterinarian. IDEXX Laboratories may publish results and data collected from this study, provided that if this study is published, only a summary of results and data will be shown and your identity or that of your pet will not be disclosed.
IDEXX Laboratories will report the results of the blood analysis to your veterinarian, who will communicate them to you.
If you have any questions concerning the research project, please feel free to ask at any point.