** PLEASE NOTE: This study is closed/completed and is not recruiting new participants **
Study Background & Purpose:
Cancer is a devastating disease affecting as many as 1 out of 3 dogs over their lifetime and is by far the most common cause of death in dogs. As in people, if we can detect cancer early enough, we can greatly improve the chances of successful treatment and in many cases we can even cure it.
We are conducting a research study to develop a test for the detection, characterization, and management of cancer in dogs. We hope to achieve this by measuring certain markers in blood that are specific to cancer but are not found in healthy dogs or in dogs with non-cancerous conditions. Assessing potential blood biomarkers, tissue samples and clinical data may support the development of a noninvasive test for the early detection of cancer. For example, 4Paws Dx (the Sponsor) develops and commercializes innovative molecular diagnostic laboratory-developed tests (LDTs) for veterinary applications.
Study participation is expected to last for approximately 30 days, across 2 clinic visits, including the day of your dog’s scheduled surgical biopsy or surgical removal.
Incentives:
- Costs associated with determining the stage of your dog’s cancer, up to $1000 CAD
Samples required:
- For specific assessmets and tests performed during baseline visits and follow up visits (within 3-30 days after surgery), please refer to the client consent and information sheets provided by clinicians.
- These can include: collection of demographic data, clinical data about the patient’s diagnosis, medication history; blood work, urinalysis, diagnosic imaging, other diagnostic testing as required; any treatments involved with the patient’s care plan
- Within 8 hours prior to the scheduled surgical biopsy or surgical removal, blood will be collected concurrent with any required for diagnostic testing and monitoring.
- If your dog is less than or equal to 22 lbs (10 kg), approximately 8.0 mL (less than 2 teaspoons) will be collected.
- If your dog is greater than 22 lbs (10 kg), approximately 16.0 mL (slightly more than 1 tablespoon) will be collected.
- (OPTIONAL) You can also consent to the collection of an additional 5 mL of blood (1 teaspoon) for future research to improve the performance of the test being developed by the Sponsor.
- Tissue collection: Immediately following surgical biopsy or surgical removal, a fragment of the mass approximately 2mm x 2mm x 10mm will be collected for the sponsor; up to 5 such fragments may be collected, depending on the size of the overall mass. The remaining tissue will be sent to your veterinarian’s laboratory for analysis, as part of their standard practice.
- All leftover or remnant samples remaining after the completion of this Study may be stored by the Sponsor for future research programs.
Inclusion Criteria:
- Dogs 1 year of age or older, weighing a minimum of 12 pounds (approximately 5.5 kg)
- A current or suspected diagnosis of cancer
- Scheduled for either a surgical biopsy or surgical removal of a mass that is known or suspected to be cancerous
Researchers:
- Dr. Brenda Coomber (PI)
Contact:
Vicky Sabine (PhD), Clinical Research Coordinator, OVC
Email: ovc.clinicaltrials@uoguelph.ca; Work Cell #: 226-218-0338