We are seeking participants for two ground-breaking clinical studies relating to early disease detection and new treatments

Review the information below to see if your dog might be eligible, then register your interest by completing this online questionnaire

QUESTIONS? Contact us at UCClinicalTrials@ncsu.edu

Clinical Study 1

Early Detection Screening of Dogs

for Bladder and Prostate Cancer

Principal investigators

Drs. Shelly Vaden and Matthew Breen

What are the aims of the study?

Canine bladder/prostate cancer is typically diagnosed after clinical signs have become evident (such as inappropriate urination, straining to urinate, and blood in the urine). By this time the disease is often at a relatively advanced stage, and the prognosis is guarded.

This study is screening urine samples from clinically healthy dogs of breeds with an increased risk of bladder/prostate cancer, to identify those that test positive for a genetic marker of the disease (a specific mutation in the dog BRAF gene). This test was developed at North Carolina State University (NCSU) and is referred to as the NCSU BRAF mutation detection test. The goal of the study is to determine the time period between detection of the genetic marker in urine of healthy dogs and the development of clinical signs of bladder/prostate cancer.

Is my dog eligible for the study?

To be eligible for enrollment a dog must meet ALL of the following criteria:

1. be aged six years or older at the time of enrollment
2. be from one of the following breeds
   American Eskimo Dog, Beagle, Russell Terrier, Parson Russell Terrier, Scottish Terrier, Shetland Sheepdog, West Highland White Terrier, Wire Hair Fox Terrier
3. have no prior diagnosis of bladder/prostate cancer (also known as urothelial carcinoma or transitional cell carcinoma)
4. have no history of bladder masses
5. have no clinical signs of lower urinary tract disease (such as inappropriate urination, straining to urinate, blood in the urine)

What does participation involve?

Participants will be asked to collect a urine sample from their dog and submit it to the study for NCSU’s BRAF mutation detection testing

• • samples can be collected by the owner at home (no need for a clinic visit)
  • sample collection pots and pre-paid return shipping materials are provided
  • the cost of BRAF Mutation Detection Testing is covered by the study

If the BRAF mutation is detected in the urine sample, participants will be asked to:

1. bring their dog for an initial clinical evaluation at the NC State College of Veterinary Medicine, or one of our partner clinics (at no cost to the owner)
2. submit a urine sample from their dog to the study each month for NCSU BRAF mutation re-testing (at no cost to the owner)
3. complete a short online questionnaire each month regarding their dog’s wellness
4. bring their dog for periodic re-evaluation at the discretion of the study clinician

If the BRAF mutation is NOT detected in the urine sample, the dog is ineligible to move forward with the study. Owners may be invited to submit another sample from their dog for retesting at a later date (at no cost).

What are the study benefits?

For eligible dogs, the following may be provided at no cost to the owner:

• clinical evaluation of their dog for the presence of bladder cancer at the NC State College of Veterinary Medicine, or one of our partner clinics

This may include detailed physical examination, bloodwork, urinalysis, ultrasound, cystoscopy and biopsy of any visible lesions

• monthly screening of their dog’s urine with the NCSU BRAF mutation detection test
• periodic clinical re-evaluation at the NC State College of Veterinary Medicine, or one of our partner clinics

Dogs that test positive for the BRAF mutation may also be eligible to enroll in a parallel study that aims to determine if daily intake of a dietary supplement can delay the onset of clinical signs.

    Clinical Study 2 – Therapeutic Trial for Dogs with Bladder Cancer

Principal investigators

Drs. Shelly Vaden and Matthew Breen

What are the aims of the study?

This study is a double-blinded therapeutic trial of a nutritional supplement for dogs commencing treatment following a recent diagnosis of bladder cancer. The goal is to determine whether the addition of the supplement to a conventional treatment regimen improves survival for dogs diagnosed with bladder cancer.

Is my dog eligible for the study?

This study is open to dogs of any age, breed, and sex.

To be eligible for enrollment a dog must meet BOTH of the following criteria:

1. must have received a diagnosis of bladder cancer within the previous three months (dogs without a formal diagnosis may be eligible if they have a measurable bladder mass identified by ultrasound)

         NOTE: dogs without a formal diagnosis of bladder cancer MAY be eligible if a measurable bladder mass has been identified by ultrasound

2. must NOT have received any cytotoxic chemotherapy or radiation treatment

          NOTE: treatment with a non-steroidal anti-inflammatory drug, or NSAID, is acceptable

What does participation involve?

Participants will be asked to collect a urine sample from their dog and submit it to the study for NCSU BRAF mutation detection testing

• samples can be collected by the owner at home (no need for a clinic visit)
• sample collection pots and pre-paid return shipping materials are provided
• the cost of NCSU BRAF mutation detection testing is covered by the study

If the BRAF mutation is detected in the urine sample, participants will be asked to:

1. bring their dog for an initial clinical evaluation at the NC State College of Veterinary Medicine, or one of our partner clinics
2. return with their dog for periodic treatment and clinical evaluation (typically every 1-3 months)
3. provide your dog with the supplied dietary supplement or placebo (a once-daily tablet)
4. submit a urine sample from their dog to the study each month for NCSU BRAF mutation re-testing
5. complete a short online questionnaire each month regarding their dog’s wellness

If the BRAF mutation is NOT detected in the urine sample, the dog is ineligible to move forward with the study. Owners may be invited to participate in related studies at a later date.

What are the study benefits?

For eligible dogs, the following may be provided at no cost to the owner:

• clinical evaluation of their dog for the presence of bladder cancer at the NC State College of Veterinary Medicine, or one of our partner clinics

This may include detailed physical examination, bloodwork, urinalysis, ultrasound, cystoscopy and biopsy of any visible lesions

• standard of care treatment

This may include an NSAID with or without cytotoxic chemotherapy (typically piroxicam and/or mitoxantrone)

• a daily dietary supplement or placebo
• monthly screening of their dog’s urine with the NCSU BRAF mutation detection test
• periodic clinical re-evaluation at the NC State College of Veterinary Medicine, or one of our partner clinics

Need help collecting urine from your dog?   Watch this video!