The Cxbladder Rule-out of Recurrent Urothelial Carcinoma

NCT03673202 | Unknown

• 1 other identifier: Waiting
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is designed to collect urine and relevant clinical information from patients who have a known diagnosis of bladder cancer and currently on clinically driven surveillance. The study aims to compare the urine test to the flexible cystoscopy procedure (which the patient is already scheduled).

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with bladder cancer who are correctly identified as having cancer (true positives) and no cancer (true negatives) by the Cxbladder test.

  To validate the Performance Characteristics (sensitivity, area under the ROC curve, positive and negative predictive values and test negative rate) of the Cxbladder for the detection of recurrent UC in the absence of inflammation 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 confirmed by pathology, plus any follow up investigations relating to the current visit.

  24 months

Secondary Outcomes (5)

• Detection rates of Cx bladder test

  24 months

• Comparison of Cxbladder theoretical capacity to reduce use of flexible cystoscopy for the monitoring for recurrence of urothelial carcinoma

  24 months

• Comparison of the Cxbladder test and cytology test performance on the same sample

  12 months

• Performance of Cxbladder test in atypical findings of cytology and cystoscopy

  24 months

• Examine urinary microbiome profile in patients with urothelial cancer

  24 months

Study Arms (1)

UC monitoring patients

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

Diagnostic Test: Cx bladder Monitor test

Interventions

Cx bladder Monitor test DIAGNOSTIC_TEST

Cxbladder Monitor is a non-invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma and also two clinical variables (whether the previous tumor was primary or recurrent and the time since the previous tumor was resected).

UC monitoring patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing flexible cystoscopy on a clinically determined surveillance schedule who have been previous diagnosed with bladder cancer are eligible. These patients are recruited prior to their investigation, and a urine sample collected. The patients clinical events are then followed (observed) for 12 months following the urine sample collection.

You may qualify if:

• Patient is undergoing investigative cystoscopies for the monitoring of recurrence of urinary tract UC at intervals prescribed by the clinical practitioner
• Patients on an "all-comers" basis
• Positive diagnosis for primary or recurrent bladder tumour within the past 5 years
• Able 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

You may not qualify if:

• Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection,
• Patients who had exposure to intravesical BCG, had completed induction BCG but without a subsequent clear cystoscopy
• Recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders,
• Recent history of pyelonephritis
• Total cystectomy of the bladder, neo bladders and illeal conduits
• Previous muscle invasive bladder tumour (pT2 or greater)

Sponsors & Collaborators

• London Health Sciences Centre: lead
• Pacific Edge Limited: collaborator

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (12)

• Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. doi: 10.3322/canjclin.55.2.74.

  PMID: 15761078 BACKGROUND

• Parekh DJ, Bochner BH, Dalbagni G. Superficial and muscle-invasive bladder cancer: principles of management for outcomes assessments. J Clin Oncol. 2006 Dec 10;24(35):5519-27. doi: 10.1200/JCO.2006.08.5431.

  PMID: 17158537 BACKGROUND

• O'Sullivan P, Sharples K, Dalphin M, Davidson P, Gilling P, Cambridge L, Harvey J, Toro T, Giles N, Luxmanan C, Alves CF, Yoon HS, Hinder V, Masters J, Kennedy-Smith A, Beaven T, Guilford PJ. A multigene urine test for the detection and stratification of bladder cancer in patients presenting with hematuria. J Urol. 2012 Sep;188(3):741-7. doi: 10.1016/j.juro.2012.05.003. Epub 2012 Jul 19.

  PMID: 22818138 BACKGROUND

• Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.

  PMID: 16442208 BACKGROUND

• Jocham D, Stepp H, Waidelich R. Photodynamic diagnosis in urology: state-of-the-art. Eur Urol. 2008 Jun;53(6):1138-48. doi: 10.1016/j.eururo.2007.11.048. Epub 2007 Dec 10.

  PMID: 18096307 BACKGROUND

• Grossman HB, Messing E, Soloway M, Tomera K, Katz G, Berger Y, Shen Y. Detection of bladder cancer using a point-of-care proteomic assay. JAMA. 2005 Feb 16;293(7):810-6. doi: 10.1001/jama.293.7.810.

  PMID: 15713770 BACKGROUND

• Dyrskjot L, Thykjaer T, Kruhoffer M, Jensen JL, Marcussen N, Hamilton-Dutoit S, Wolf H, Orntoft TF. Identifying distinct classes of bladder carcinoma using microarrays. Nat Genet. 2003 Jan;33(1):90-6. doi: 10.1038/ng1061. Epub 2002 Dec 9.

  PMID: 12469123 BACKGROUND

• Dyrskjot L, Zieger K, Kruhoffer M, Thykjaer T, Jensen JL, Primdahl H, Aziz N, Marcussen N, Moller K, Orntoft TF. A molecular signature in superficial bladder carcinoma predicts clinical outcome. Clin Cancer Res. 2005 Jun 1;11(11):4029-36. doi: 10.1158/1078-0432.CCR-04-2095.

  PMID: 15930337 BACKGROUND

• Thykjaer T, Workman C, Kruhoffer M, Demtroder K, Wolf H, Andersen LD, Frederiksen CM, Knudsen S, Orntoft TF. Identification of gene expression patterns in superficial and invasive human bladder cancer. Cancer Res. 2001 Mar 15;61(6):2492-9.

  PMID: 11289120 BACKGROUND

• Scott V, Morgan EA, Stadler HS. Genitourinary functions of Hoxa13 and Hoxd13. J Biochem. 2005 Jun;137(6):671-6. doi: 10.1093/jb/mvi086.

  PMID: 16002988 BACKGROUND

• Beattie J, Allan GJ, Lochrie JD, Flint DJ. Insulin-like growth factor-binding protein-5 (IGFBP-5): a critical member of the IGF axis. Biochem J. 2006 Apr 1;395(1):1-19. doi: 10.1042/BJ20060086.

  PMID: 16526944 BACKGROUND

• Kadomatsu K, Muramatsu T. Midkine and pleiotrophin in neural development and cancer. Cancer Lett. 2004 Feb 20;204(2):127-43. doi: 10.1016/S0304-3835(03)00450-6.

  PMID: 15013213 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Patients urine specimen are analysed for the test; kept in storage for 10 years for potential future research.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jonathan Izawa, MD

  Schulich School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiva M Nair, MD, PhD

CONTACT

5196858500; shiva.nair@lhsc.on.ca

Kaydee Connors, BSc

CONTACT

5196858500; kaydee.connors@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 17, 2018
• Study Start: November 26, 2018
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)