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The Cxbladder Hematuria Clinical Utility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988309
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Pacific Edge Limited

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hematuria Urothelial Carcinoma Diagnostic Test: Cxbladder Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of a Multiplexed Molecular Biomarker Test Cxbladder, in Real World Decision Making to Provide Clinical Utility Using a Randomized Design
Actual Study Start Date : September 11, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Test, subjects categorised as "low risk" or "Not low risk"
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.
Diagnostic Test: Cxbladder
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. "Not low risk" patients will be evaluated as per standard of care.

No Intervention: Control
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.



Primary Outcome Measures :
  1. To measure the change in cystoscopy procedure use count between control and test arms when Cxbladder is used in the evaluation [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    To evaluate the increase in utility as defined by the reduction in cystoscopy procedure count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis. The gold standard for determination of a confirmed clinical diagnosis is cystoscopy confirmed by pathology, plus imaging or any follow-up investigations relating to the visit.


Secondary Outcome Measures :
  1. To measure the change in total procedure use (and the invasive procedure sub-group) count between control and test arms when Cxbladder is used in the evaluation. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    To evaluate the increase in utility as defined by the reduction in total procedures (and the invasive procedures subgroup) count when Cxbladder is used in the evaluation. The comparison will be made when comparing test and control arms on a per subject basis.

  2. To measure the proportion of subjects who were ruled out on the test arm when Cxbladder is used in the evaluation [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    To quantify the 'rule-out' percentage (proportion ruled out from further evaluation by the physician) when Cxbladder is used in the evaluation.

  3. To measure the number of subjects who were incorrectly diagnosed associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    To quantify the false negative rate (the percentage of the negative fraction incorrectly diagnosed) associated with the integration of Cxbladder into the evaluation of subjects (or sub-cohorts on test and control arms) presenting with hematuria for evaluation of UC

  4. Proportion of subjects (and sub-groups within test and control arms) with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    The Cxbladder test results will be compared to that of cystoscopy, which is the gold standard method for diagnosing urothelial cancer; the true positive and true negative rates will be measured, along with the false positive and false negative rates of the test. The results will be reported as sensitivity and specificity of the Cxbladder test for detecting urothelial cancer in patients referred for evaluation of hematuria.

  5. To compare the total score of the anxiety and pain level associated with cystoscopy vs Cxbladder by using Patient Result Outcome questionnaire and WIWI(was it worthy it) [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    Subjects will have Patient Reported Outcomes at enrollment for all subjects on the test arm to set a baseline and post cystoscopy for all subjects on the test arm. For all of the PROMIS short forms we will report PROMIS T-scores. For both measures, the raw score will be converted to a T-score which rescales the raw score into a standardized score that ranges from 0 to 100 with a mean of 50 and a standard deviation of 10. Anxiety level has four questions with five scales of answers. Pain level has three questions with five scales of answers. WIWI has 6 questions on the three scales to describe answers.

  6. Comparison of the Cxbladder test's sensitivity, specificity, PPV and NPV with that of Cytology. [ Time Frame: The outcome measure will be assessed by 6 months after trial completion. ]
    Probability that patients identified as having cancer and no cancer by the Cxbladder test truly have cancer (positive predictive value; PPV), and truly have no cancer (negative predictive value; NPV) respectively. Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to urine cytology, in addition to the gold standard test (cystoscopy). All comparator tests will be carried out on the same voided urine sample used for Cxbladder tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  1. Patient is undergoing investigation of recent confirmed hematuria (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.
  2. Able to provide a voided urine sample of the required minimum volume
  3. Able to give written consent
  4. Able and willing to comply with study requirements
  5. Aged 18 years or older

Exclusion Criteria

  1. Prior history of bladder malignancy, prostate or renal cell carcinoma
  2. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
  3. History of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis
  4. Previous alkylating based chemotherapy
  5. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988309


Contacts
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Contact: Yair Lotan, MD 2146458764 yair.lotan@utsouthwestern.edu

Locations
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United States, California
Institute of Urology, USC Norris Comprehensive Cancer Center Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Ileana Aldana    323-865-0702    ileana.aldana@med.usc.edu   
Principal Investigator: Sumeet Bhanvadia         
United States, Minnesota
University of Minnesota, Department of Urology Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Bethany Marlette    612-626-6661    marle025@umn.edu   
Principal Investigator: Badrinath Konety         
United States, Pennsylvania
Division of urology, Penn State Milton S Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Kathy Lehman    717-531-5930    klehman3@pennstatehealth.psu.edu   
Principal Investigator: Jay Raman         
United States, Tennessee
Department of Urology,Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Pamela Steele    615-343-2120    pamela.steele@vumc.org   
Principal Investigator: Kristin Scarpato         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Jess Ramos    214-645-8764    jess.ramos@UTSouthwestern.edu   
Principal Investigator: Yair Lotan, MD         
Canada, British Columbia
The prostate centre- Diamond Health care centre Recruiting
Vancouver, British Columbia, Canada, V5Z1M9
Contact: Sarah Charlesworth    604-875-4111 ext 69308    scharlesworth@prostatecentre.com   
Principal Investigator: Peter Black         
Canada, Ontario
London Health Sciences Centre Victoria Hospital Not yet recruiting
London, Ontario, Canada, N6A5W9
Contact: Kaydee Connors    519-685-8455 ext 56366    kaydee.connors@lhsc.on.ca   
Principal Investigator: Jonathan Izawa         
Sponsors and Collaborators
Pacific Edge Limited
Investigators
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Study Chair: Tony Lough, PhD Pacific Edge Pty Ltd

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Responsible Party: Pacific Edge Limited
ClinicalTrials.gov Identifier: NCT03988309    
Other Study ID Numbers: CXB/2019/US
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Hematuria
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urination Disorders
Urologic Diseases
Hemorrhage
Pathologic Processes