Detection of Disease in the Upper Tract

Upper Tract Urinary Carcinoma Clinical Trial

— DEDUCT  

Official title:

An Observational Study of Cxbladder Performance for Detection or Rule-out of Upper Tract Urothelial Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05349812
• Other study ID #: Pacificedgedx
• Status: Withdrawn
• Start date: November 2022
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Pacific Edge Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational study of Cxbladder performance for detection or rule-out of upper tract urothelial cancer. Subjects will be prospectively recruited to a single arm observational study to validate the performance characteristics of Cxbladder for suspected (UTUC) or for patients with a history of UTUC and are under surveillance for recurrence of disease.

Description:

This is a single arm observational study prospectively recruiting eligible subjects with no apparent UC of the bladder following white light cystoscopy who have positive or suspicious urine cytology or imaging results.

Participants will undergo all clinical investigations as prescribed by the physician as per standard of care with addition of urine sampling to enable Cxbladder and central urine cytology testing. A mid-stream voided urine sample collected at the time of appointment will be used for Cxbladder and central urine cytology testing. Cxbladder and central cytology results will not be reported to the physician.

Urine sample testing will occur at Pacific Edge Ltd laboratories (Dunedin, New Zealand). Central urine cytology will be processed by an independent testing laboratory (Southern Community Laboratories, Dunedin, New Zealand). The remainder of the urine sample will be used for dipstick analysis of Specific Gravity, Leucocytes, Nitrites, Blood, Haemoglobin, and pH. The unused portion of this sample will be used for local cytology and any other analysis as deemed clinically appropriate. Central urine cytology results are not available to physicians.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Suspected to have UTUC following negative cystoscopy but positive or suspicious imaging and/or urine cytology.

2. Under surveillance for UTUC following a previous confirmed diagnosis of UTUC

3. Able to provide a voided urine sample of the required 30 ml minimum volume

4. Able to give written consent

5. Able and willing to comply with study requirement

6. Aged 18 years or older

Exclusion Criteria:

1. Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection

2. Total cystectomy of the bladder with bowel urinary diversion

3. Pregnancy

Related Conditions & MeSH terms

• Carcinoma
• Upper Tract Urinary Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Edge Limited

References & Publications (25)

Amis ES Jr, Butler PF, Applegate KE, Birnbaum SB, Brateman LF, Hevezi JM, Mettler FA, Morin RL, Pentecost MJ, Smith GG, Strauss KJ, Zeman RK; American College of Radiology. American College of Radiology white paper on radiation dose in medicine. J Am Coll Radiol. 2007 May;4(5):272-84. doi: 10.1016/j.jacr.2007.03.002. — View Citation

Breen V, Kasabov N, Kamat AM, Jacobson E, Suttie JM, O'Sullivan PJ, Kavalieris L, Darling DG. A holistic comparative analysis of diagnostic tests for urothelial carcinoma: a study of Cxbladder Detect, UroVysion(R) FISH, NMP22(R) and cytology based on imputation of multiple datasets. BMC Med Res Methodol. 2015 May 12;15:45. doi: 10.1186/s12874-015-0036-8. — View Citation

Cowan NC, Turney BW, Taylor NJ, McCarthy CL, Crew JP. Multidetector computed tomography urography for diagnosing upper urinary tract urothelial tumour. BJU Int. 2007 Jun;99(6):1363-70. doi: 10.1111/j.1464-410X.2007.06766.x. Epub 2007 Apr 8. — View Citation

Cowan NC. CT urography for hematuria. Nat Rev Urol. 2012 Mar 13;9(4):218-26. doi: 10.1038/nrurol.2012.32. — View Citation

Davidson PJ, McGeoch G, Shand B. Assessment of a clinical pathway for investigation of haematuria that reduces the need for cystoscopy. N Z Med J. 2020 Dec 18;133(1527):71-82. — View Citation

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Inman BA, Tran VT, Fradet Y, Lacombe L. Carcinoma of the upper urinary tract: predictors of survival and competing causes of mortality. Cancer. 2009 Jul 1;115(13):2853-62. doi: 10.1002/cncr.24339. — View Citation

Janisch F, Shariat SF, Baltzer P, Fajkovic H, Kimura S, Iwata T, Korn P, Yang L, Glybochko PV, Rink M, Abufaraj M. Diagnostic performance of multidetector computed tomographic (MDCTU) in upper tract urothelial carcinoma (UTUC): a systematic review and meta-analysis. World J Urol. 2020 May;38(5):1165-1175. doi: 10.1007/s00345-019-02875-8. Epub 2019 Jul 18. — View Citation

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. — View Citation

Johannes JR, Nelson E, Bibbo M, Bagley DH. Voided urine fluorescence in situ hybridization testing for upper tract urothelial carcinoma surveillance. J Urol. 2010 Sep;184(3):879-82. doi: 10.1016/j.juro.2010.05.023. — View Citation

Kavalieris L, O'Sullivan P, Frampton C, Guilford P, Darling D, Jacobson E, Suttie J, Raman JD, Shariat SF, Lotan Y. Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter Study. J Urol. 2017 Jun;197(6):1419-1426. doi: 10.1016/j.juro.2016.12.010. Epub 2016 Dec 14. — View Citation

Kavalieris L, O'Sullivan PJ, Suttie JM, Pownall BK, Gilling PJ, Chemasle C, Darling DG. A segregation index combining phenotypic (clinical characteristics) and genotypic (gene expression) biomarkers from a urine sample to triage out patients presenting with hematuria who have a low probability of urothelial carcinoma. BMC Urol. 2015 Mar 27;15:23. doi: 10.1186/s12894-015-0018-5. — View Citation

Konety B, Shore N, Kader AK, Porten S, Daneshmand S, Lough T, Lotan Y. Evaluation of Cxbladder and Adjudication of Atypical Cytology and Equivocal Cystoscopy. Eur Urol. 2019 Aug;76(2):238-243. doi: 10.1016/j.eururo.2019.04.035. Epub 2019 May 16. — View Citation

Koya M, Osborne S, Chemasle C, Porten S, Schuckman A, Kennedy-Smith A. An evaluation of the real world use and clinical utility of the Cxbladder Monitor assay in the follow-up of patients previously treated for bladder cancer. BMC Urol. 2020 Feb 11;20(1):12. doi: 10.1186/s12894-020-0583-0. — View Citation

Linet MS, Kim KP, Rajaraman P. Children's exposure to diagnostic medical radiation and cancer risk: epidemiologic and dosimetric considerations. Pediatr Radiol. 2009 Feb;39 Suppl 1(Suppl 1):S4-26. doi: 10.1007/s00247-008-1026-3. Epub 2008 Dec 16. — View Citation

Lotan Y, O'Sullivan P, Raman JD, Shariat SF, Kavalieris L, Frampton C, Guilford P, Luxmanan C, Suttie J, Crist H, Scherr D, Asroff S, Goldfischer E, Thill J, Darling D. Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma. Urol Oncol. 2017 Aug;35(8):531.e15-531.e22. doi: 10.1016/j.urolonc.2017.03.008. Epub 2017 Mar 31. — View Citation

McHale T, Ohori NP, Cieply KM, Sherer C, Bastacky SI. Comparison of urinary cytology and fluorescence in situ hybridization in the detection of urothelial neoplasia: An analysis of discordant results. Diagn Cytopathol. 2019 Apr;47(4):282-288. doi: 10.1002/dc.24108. Epub 2018 Nov 12. — View Citation

Messer J, Shariat SF, Brien JC, Herman MP, Ng CK, Scherr DS, Scoll B, Uzzo RG, Wille M, Eggener SE, Steinberg G, Terrell JD, Lucas SM, Lotan Y, Boorjian SA, Raman JD. Urinary cytology has a poor performance for predicting invasive or high-grade upper-tract urothelial carcinoma. BJU Int. 2011 Sep;108(5):701-5. doi: 10.1111/j.1464-410X.2010.09899.x. Epub 2011 Feb 14. — View Citation

Mettler FA Jr, Huda W, Yoshizumi TT, Mahesh M. Effective doses in radiology and diagnostic nuclear medicine: a catalog. Radiology. 2008 Jul;248(1):254-63. doi: 10.1148/radiol.2481071451. — View Citation

Mowatt G, Zhu S, Kilonzo M, Boachie C, Fraser C, Griffiths TR, N'Dow J, Nabi G, Cook J, Vale L. Systematic review of the clinical effectiveness and cost-effectiveness of photodynamic diagnosis and urine biomarkers (FISH, ImmunoCyt, NMP22) and cytology for the detection and follow-up of bladder cancer. Health Technol Assess. 2010 Jan;14(4):1-331, iii-iv. doi: 10.3310/hta14040. — View Citation

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. — View Citation

Raman JD, Messer J, Sielatycki JA, Hollenbeak CS. Incidence and survival of patients with carcinoma of the ureter and renal pelvis in the USA, 1973-2005. BJU Int. 2011 Apr;107(7):1059-64. doi: 10.1111/j.1464-410X.2010.09675.x. Epub 2010 Sep 3. — View Citation

Royal HD. Effects of low level radiation-what's new? Semin Nucl Med. 2008 Sep;38(5):392-402. doi: 10.1053/j.semnuclmed.2008.05.006. — View Citation

Takahashi N, Glockner JF, Hartman RP, King BF, Leibovich BC, Stanley DW, Fitz-Gibbon PD, Kawashima A. Gadolinium enhanced magnetic resonance urography for upper urinary tract malignancy. J Urol. 2010 Apr;183(4):1330-65. doi: 10.1016/j.juro.2009.12.031. Epub 2010 Feb 19. — View Citation

VandenBussche CJ, Allison DB, Gupta M, Ali SZ, Rosenthal DL. A 20-year and 46,000-specimen journey to Paris reveals the influence of reporting systems and passive peer feedback on pathologist practice patterns. Cancer Cytopathol. 2018 Jun;126(6):381-389. doi: 10.1002/cncy.22006. Epub 2018 May 14. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of Cxbladder for the detection of Upper Tract Urothelial Carcinoma (UTUC)	The number of subjects identified with UTUC by Cxbladder testing as verified by the gold standard for clinical diagnosis.	Up to 36 months