Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Hematuria

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Hemorrhage

Transitional Cell Carcinoma

Patients will be recruited from those presenting with hematuria and undergoing investigative cystoscopy for the determination of possible urothelial carcinoma. This includes patients referred via imaging or from other departments for assessment of hematuria. Microscopic hematuria is defined as \> 3 red blood cells per high-powered microscopy field for a properly collected urine sample.

The Cxbladder Detect test, developed by Pacific Edge Ltd (O'Sullivan 2012; Holyoake 2008; National Health Committee 2015b) is a molecular diagnostic test, which consists of five mRNA transcripts measured in a small volume of urine.

Cxbladder

Tony Lough, PhD

Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.

Non-invasive, voided urine sample used for both Cxbladder molecular tests, voided urine sample may be used for standard of care testing. Retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management.

The study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple Veterans Affairs sites

A minimum of 30 mL of urine will be required for the sampling system to function. Two 5 mL aliquots of the collected urine will be transferred to a vacutainer containing a preservative reagent, and couriered to Pacific Edge Diagnostic NZ Laboratories.

Efficacy and Utility of Cxbladder Tests in Hematuria Patients

An Observational Study of Efficacy and Utility of Cxbladder Tests in the Identification of Low vs High Risk Patients and the Detection of Urothelial Carcinoma in Patients Presenting With Hematuria

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 with hematuria

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 with recurrent disease.

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.

To compare the theoretical clinical outcome of patients tested using Cxbladder tests in combination (Triage followed by Detect and / or Resolve) before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.

To compare the theoretical clinical outcome of patients tested using Cxbladder signatures before investigative cystoscopy with evaluation by (positive, negative or suspicious) cystoscopy alone to establish the true proportion requiring cystoscopy, thereby determining the potential of Cxbladder to reduce or adjudicate the cystoscopy burden of hematuria patients and/or sub cohorts under clinical evaluation in a hospital urology clinic setting.

To evaluate the performance characteristics of Cxbladder Triage and Cxbladder Detect compared with results generated at other clinical sites, and to the results of the pulished clinical studies by O'Sullivan et al in 2012 and Kavalieris et al in 2015

Pacific Edge Limited

Recurrence

Patients undergoing investigative cystoscopy for the detection of urothelial carcinoma as part of a standard-of-care schedule of investigations.

All patients will have urine samples taken and analyzed for NMP22 ELISA, NMP22 BladderChek, urine cytology and Cxbladder.

No results for any tests under evaluation in this study are provided to the clinician for diagnostic purposes.

Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.

Paul J O'Sullivan, PhD

The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated according to standard practice and are undergoing routine investigative cystoscopy.

The gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.

De-identified, consented participant samples of between 5mL and 15 mL of urine, stabilized in the proprietary Cxbladder liquid, will be stored at -80ºC for further urinary diagnostic assay development and improvement.

The Cxbladder Monitoring Study

A Clinical, Non-intervention Study of the Cxbladder Urine Test for the Detection of Recurrent Urothelial Carcinoma (UC)

Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 ELISA, 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.

Performance characteristics (sensitivity, specificity, PPV and NPV) of the Cxbladder test for detecting recurring urothelial cancer will be compared to NMP22 BladderChek, 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Utility of Cxbladder Tests in Hematuria Patients	NCT04943380	Hematuria Urothelial Carc...	Cxbladder	18 Years -	Pacific Edge Limited
Efficacy and Utility of Cxbladder Tests in Hematuria Patients	NCT04943380	Hematuria Urothelial Carc...	Cxbladder	18 Years -	Pacific Edge Limited
The Cxbladder Monitoring Study	NCT02700659	Urothelial Carc...	Cxbladder	18 Years -	Pacific Edge Limited

Spots Global Cancer Trial Database for cxbladder

Every month we try and update this database with for cxbladder cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cxbladder

Every month we try and update this database with for cxbladder cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cxbladder cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.