Matthew Breen :: PhD :: C.Biol :: FRSB ::
Professor of Genomics and the Oscar J. Fletcher Distinguished Professor of Comparative Oncology Genetics

BLADDER CANCER - DIETARY TREATMENT AND EARLY DETECTION STUDIES

Clinical Study 1: Therapeutic Trial for Dogs with Bladder Cancer

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. The goal of this study is to determine if adding this dietary supplemental to standard of care bladder cancer therapy 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 containers
  • If 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 continued treatment with 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

01/01/2023

Eligibility

To qualify, your dog must have:
– A diagnosis of bladder cancer (UC) via cytology or biopsy within the past 6 weeks
– A measurable mass in the bladder visible on ultrasound in the past 6 weeks
– Detectable BRAF mutation in the urine in the past 6 weeks
– Treatment with chemotherapy (typically mitoxantrone and piroxicam)

    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 seven breeds (Scottish terrier, beagle, West Highland white terrier, Shetland sheepdog, American Eskimo dog, Parson Russell terrier, Russell 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 at no cost to you.

    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. Through the support of the Morris Animal Foundation, researchers at the NC State College of Veterinary Medicine are evaluating a newly developed test to see if it is capable of early detection of urothelial carcinoma.

    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 >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.

    Early stage urothelial carcinoma lesion

    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. 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.