STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA

Pacific Edge

Status: Completed

Conditions: Hematuria; Urothelial Carcinoma

Treatments: Diagnostic Test: Cxbladder

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988309

CXB/2019/US

Details and patient eligibility

About

To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.

Full description

Randomised two arm pragmatic clinical study to be conducted at multiple sites in US and Canada. The trial will recruit hematuria subjects, presenting to qualified sites (academic, community), who are being evaluated for urothelial carcinoma (UC). Up to 100 consecutive eligible subjects will be recruited per site.

Enrollment: 554 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient is undergoing investigation of recent confirmed hematuria, as defined by the AUA/SUFU Guideline (Barocas DA, Boorjian SA, Alvarez RD et al. Microhematuria: AUA/SUFU guideline, J Urol 2020; 204:778) (by either flexible or rigid cystoscopy/TURBT), including hematuria subjects referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma.
• Able to provide a voided urine sample of the required minimum volume
• Able to give written consent
• Able and willing to comply with study requirements
• Aged 18 years or older

Exclusion Criteria

• Prior history of bladder malignancy or pelvic radiotherapy. Prior history prostate or renal cell carcinoma within the last 5 years.
• Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
• Known current pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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554 participants in 2 patient groups

Test, subjects categorised as "low risk" or "Not low risk"

Active Comparator group

Description:

A clinical risk factor nomogram risk classification will be used in this study. The nomogram categorizes subjects as either "low risk" or "not low risk" categories. "Low risk" subjects satisfy all conditions and "not low risk" satisfies at least one of the conditions.The Cxbladder Triage test result will be provided to physicians for all "low risk" subjects on the test arm. If a "low risk" subject has a Cxbladder Triage negative test result then the indication is to rule out the subject without further assessment. The decision to rule-out or further evaluate is solely that of the physician and subject. If the "low risk" subjects are not Cxbladder Triage negative then a Cxbladder Detect test result will also be provided. The indication is further evaluation as per standard of care. Subjects categorised as "not low risk" will be evaluated as per standard of care. Note that Cxbladder test results will be available for eventual analysis for these subjects.

Treatment:

Diagnostic Test: Cxbladder

Control

No Intervention group

Description:

Subjects on the control arm will be on standard of care. Trial nomogram clinical risk factor categorization for control arm subjects will not be provided to the physician (but appropriate information will be collected on the CRF to enable sub-group analysis) No Cxbladder test results will be provided for control arm subjects. Note that Cxbladder test results will be available for eventual analysis for these subjects.