Study to Assess the Impact of the Urine Test Cxbladder Detect+ on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

Trial Title: Study to Assess the Impact of the Urine Test Cxbladder Detect+ on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.

NCT ID: NCT06394869

Condition: Hematuria - Cause Not Known

Conditions: Official terms:
Hematuria

Conditions: Keywords:
microscopic hematuria
microhematuria
urothelial carcinoma
bladder cancer

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Diagnostic Test
Intervention name: Cxbladder Detect+
Description: Cxbladder Detect+ is a lab developed, test that is using RNA and DNA biomarkers in the urine to assess the likelihood of the presence of urothelial carcinoma in the bladder.
Arm group label: Test Arm

Summary: This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria. One of them is bladder cancer. While bladder cancer is one of the biggest worries, it is only found in few of these patients. Most microhematuria patients will have a cystoscopy to look inside the bladder. During a cystoscopy, a small camera is inserted into the bladder. This is done through the urethra, the tube that passes urine from the bladder to the outside. In some patients it can cause pain or anxiety. Not all patients have a cystoscopy. Those that don't, usually return for a urine sample within 6 months. This is done to check if there is still blood in their urine. This study is conducted to find out if the use of "Cxbladder Detect+" changes the number of cystoscopies in microhematuria patients. Cxbladder Detect+ is also called "Detect+". It is a lab test that was developed to check how likely urothelial carcinoma is present in the bladder. Urothelial carcinoma is by far the most common type of bladder cancer. For the test, the patient voids some urine into a cup. A laboratory then checks the urine of specific genetic material. Abnormalities can be a sign of urothelial carcinoma. The result indicates if the urine is more like most normal urine or more like that of urothelial carcinoma patients. The study is done to find out how Detect+ changes the number of cystoscopies. Study participants first void urine into a cup. The urine is used for the Detect+ test. The patients are then assigned to one of two groups. The assignment is random. This means the nobody can influence the assignment. The chance to be assigned to either group is the same. In the test group, the urologist will receive the Detect+ result and discuss it with the patient. Together they decide whether to do a cystoscopy. In the control group, the urologist will not receive the Detect+ result. The patient will also not get the result. The urologist and patient will follow standard of care to decide whether to do a cystoscopy. For test group patients, the study gives a recommendation whether to proceed with cystoscopy. It is based on the patient's Detect+ result. The urologist and patient do not need to follow the recommendation. If the urologist does not follow it, they will complete a survey. the patient will be asked to complete a survey if they don't follow the urologist's recommendation. If the patient does not follow the urologist's recommendation. The survey has only one question. It is asking for the reasons of the decision. After making their decision, patients will follow the chosen pathway. Data on the performed procedures are collected. The diagnosis will also be documented. Data will be collected for up to about 9 months. To see how Detect+ changes the number of cystoscopies, these will be counted in each group and then compared.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Patient is referred for assessment of microhematuria (MH) with presentation confirmed by urine microscopy of 3 or more red blood cells per high powered field (RBC/HPF) (documented by the referring physician or at the investigator site) within 90 days of enrollment. 2. Physically able to provide a voided urine sample from a bladder that has not been surgically altered. 3. Able to give informed, written consent. 4. Able and willing to comply with study requirements. 5. Aged 18 to 88 years. 6. Ability to comprehend written and spoken English sufficiently to independently follow all study procedures. Or ability to comprehend written and spoken Spanish with access to an English-Spanish interpreter for all study related verbal instructions and discussions. Exclusion Criteria: 1. Prior history of bladder malignancy. 2. Prior history of upper tract UC or prostatic urethral UC. 3. Gross hematuria within the last six months (reported in patient's records and/or during patient's interview) 4. Reconstructed or diverted bladder (e.g., bladder augmentation, ileal conduit, Indiana pouch) 5. Indication to recommend cystoscopy other than MH (e.g., bothersome benign prostatic hyperplasia symptoms and desires a procedure, weak stream with concerns for urethral stricture). 6. Cystoscopy contraindicated due to another condition or anatomy. 7. History of pelvic radiation. 8. Currently receiving chemotherapy or has had chemotherapy within the last 6 weeks. 9. History of schistosomiasis. 10. History of chronic (>3 months) indwelling Foley catheter or chronic (>3 months) bladder stones. 11. Known current pregnancy.

Gender: All

Minimum age: 18 Years

Maximum age: 88 Years

Healthy volunteers: No

Start date: December 2024

Completion date: March 2027

Lead sponsor:
Agency: Pacific Edge Limited
Agency class: Industry

Source: Pacific Edge Limited

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06394869