Breen Lab @ NCSU

Principle Investigators.

Drs. Shelly Vaden and Matthew Breen

Double-blinded therapeutic trial for dogs with a diagnosis of bladder cancer. This study will provide a nutritional supplement or placebo as an additional treatment for dogs currently receiving chemotherapy for their bladder cancer. Some dogs will also qualify for the cost of chemotherapy. The goal of this study is to determine if adding this dietary supplemental to standard of care therapy for canine bladder improves survival.

Study participants will be required to:

• Collect a urine sample from your dog.
• Ship the sample back to the laboratory using the self-addressed and postage-paid shipping container

If your dog is determined to be eligible for the study you will

1. be asked to supplement your dog’s food once per day with a supplement
2. receive follow up with designated veterinary clinic for treatment with standard of care chemotherapy
3. be asked to collect and submit a urine sample from your dog, monthly for up to 12 months.
4. receive a free BRAF mutation test on these urine samples.

Enrollment Start

03/01/2022

Enrollment Finish

ongoing

Eligibility

To qualify, your dog must be of any breed or age and have:
– A diagnosis of bladder cancer (UC) via cytology or biopsy within the past 6 weeks
– Not started treatment with chemotherapy

Interested? Please complete this questionnaire at: https://https://redcap.link/NCStateUCStudyQ1

If you have any questions, please contact us at UCClinicalTrials@ncsu.edu

Clinical Study 2: Early Detection Screening of Dogs for Bladder Cancer

Principle Investigators.

Drs. Shelly Vaden and Matthew Breen

Be part of a ground-breaking cancer screening study! We are screening healthy dogs for early signs of bladder cancer and investigating environmental exposure to chemicals, such as pesticides and flame retardants.

Study participants will be required to:

• Collect a urine sample from your dog.
• Ship the sample back to the laboratory using the self-addressed and postage-paid shipping containers.

You will receive a free BRAF mutation test on your dog’s urine.

Eligibility:

1. Dog is one of eight breeds (Scottish Terrier, Beagle, West Highland White Terrier, Shetland sheepdog, American Eskimo Dog, Parson Russell Terrier, Russell Terrier, Wire Fox Terrier) at high risk of developing a UC/TCC, or a mix related to these breeds.
2. Dog is age 6 years or older at the time of enrollment.
3. You are the legal owner of the dog.
4. Your dog has no signs of lower urinary tract disease.

If your dog tests positive for BRAF, you may be invited to receive a clinical evaluation of your dog at no cost to you and become part of parallel studies.

Enrollment Start

03/01/2022

Enrollment Finish

ongoing

Interested? Please complete this questionnaire at: https://https://redcap.link/NCStateUCStudyQ1

If you have any questions, please contact us at UCClinicalTrials@ncsu.edu

Need help collecting urine? Watch this video!

Details:

Urothelial carcinoma (UC), also referred to as transitional cell carcinoma (TCC), is a common cancer of the urinary tract 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. With support of the Morris Animal Foundation, our team at NC State College of Veterinary Medicine are evaluating molecular approaches to enhance early detection of UC/TCC. In a related study, we are assessing the impact of adding a dietary supplement to standard of care treatment of UC/TCC to overall quality and duration of life for dogs that have a diagnosis of UC/TCC.

Clinical Evaluation

The goal of the clinical study is to determine the time period from detection of a low level of the BRAF mutation in the urine to the time that the dog shows clinical signs of UC/TCC. 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 the early detection study, all dogs enrolled, the level of BRAF mutation shed into the urine will be monitored monthly. Once the urinary BRAF mutation levels reach 10%, dogs will have repeat diagnostics, including ultrasound, urine cytology, and in some cases 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. 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.  The study will not cover any costs associated with cancer treatment. However in some circumstanmces the dog may become eligible for enroling in parallel study.

For dog enrolled into the dietary supplement study, the level of BRAF mutation shed into the urine will be monitored monthly.  The study will cover the cost of all NC State provided clinical evaluations and associated BRAF testing costs throughout the study.  In some circumstances,  the study will also cover the cost of standard of care chemotherpay. The costs of procedures perfomed at partner clinicis may also be covered by the study.

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.