Research Overview

Early Diagnosis of Canine Urothelial Carcinoma

UTRACT - Urothelial carcinoma Translational Research And Clinical Trials

Click this LINK to access our lastest newsletter for this study

Click this LINK to see a video demonstrating how to collect urine from your dog 

Canine urothelial carcinoma (UC), also referred to as transitional cell carcinoma (TCC), is a common cancer of the urinary tract of dogs that is both challenging to diagnose and treat effectively. The current gold standard for UC/TCC diagnosis is via tissue biopsy, but this requires specialized equipment, sufficient tumor size for biopsy, and can be expensive for many owners. Through the support of the Morris Animal Foundation, researchers at the NC State College of Veterinary Medicine are evaluating the utility of BRAF mutation testing of free-catch urine specimens for early detection of urothelial carcinoma. The study has three stages.

Stage I - Recruitment
This clinical study involves several AKC-registered breeds at an increased risk of developing UC/TCC. With the assistance of the AKC, owners of all dogs of these breeds that reside within a five-hour driving distance of the NC State Veterinary School will be invited to respond to a questionnaire about their dog. To be considered for enrollment, you must meet all the following requirements:

• Your dog is a Beagle, Shetland sheepdog, West Highland white terrier, Scottish terrier, Parson Russell terrier, Russell terrier, or American Eskimo dog.
• You are the legal owner of the dog.
• Your dog is 6 years or older.
• Your dog has not received chemotherapy, steroids, or non-steroidal anti-inflammatories (NSAIDs, ie Rimadyl, Deramaxx, Previcox, piroxicam, etc.) in the past year.
• You confirm that if your dog is selected for participation in the study you are willing to bring your dog to the NC State Veterinary Hospital for further tests. You will be expected to cover your own transportation costs to/from NC State. The study will cover all clinical costs while at NC State.

If you are interested in participating, please complete this questionnaire: https://is.gd/NCStateUCClinicalTrial

Stage II - Screening
From the respondents, we will select ~1,000 dogs at random and invite the owners to:

• Sign an online consent form and questionnaire.
• Submit a urine sample from their dog. Upon completion of the online consent form, each dog owner will be sent a urine collection kit and prepaid return shipping materials to collect ~40 ml of urine.   

On receipt at NC State Veterinary School, each urine samples will be analyzed by BRAF mutation detection to identify dogs that are shedding a very low level of BRAF mutant cells into their urine, indicative of the presence of an early TCC/UC. The study will cover all the cost of urine collection kits, shipping costs to/from the home of the dog, and   RAF testing cost for these dogs.

Stage III – Clinical Evaluation
The goal of the clinical study is to determine the time period from detection of a low level of the BRAF mutation to the time that the dog shows clinical signs of UC/TCC. From the >1,000 dogs screened, 30 dogs with a low urinary BRAF mutation level will be invited to the NC State Veterinary Hospital for a detailed clinical evaluation through physical examination, blood tests, urinalysis, ultrasound, cystoscopy, and biopsy of any visible lesions.
For all 30 dogs, the level of BRAF mutation shed into the urine will be monitored monthly. Once the levels reach 10%, dogs will have repeat diagnostics, including ultrasound, urine cytology, and cystoscopy with biopsy. The cost of all NC State provided clinical evaluations and associated BRAF testing costs throughout the study will be covered by the study. Owners will be required to cover their own transportation costs to/from NC State Veterinary Hospital for all required on site clinical evaluations. A dog will leave the study when a definitive diagnosis of UC/TCC is made through urine cytology or histopathology of tumor biopsies. Once that formal diagnosis of UC/TCC is made, all subsequent costs for clinical management of the dog will be the responsibility of the dog’s owner/agent. The study will not cover any costs associated with cancer treatment.

If proven effective, earlier diagnosis prior to the development of clinical signs holds promise for improved survival and quality of life for the 40,000 to 80,000 dogs diagnosed each year with this devastating cancer.