Clinical trial · Observational

Detection of Disease in the Upper Tract

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

NCT05349812CI-TRIAL-00075844DEDUCTwithdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Sponsor focusing on completion of other studies at this time.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Upper Tract Urinary Carcinoma	—	UNRESOLVED	—

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Performance of Cxbladder for the detection of Upper Tract Urothelial Carcinoma (UTUC)
timeFrame
Up to 36 months
description
The number of subjects identified with UTUC by Cxbladder testing as verified by the gold standard for clinical diagnosis.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (25)

BACKGROUNDRaman 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. PMID 20825397
BACKGROUNDInman 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. PMID 19434668
BACKGROUNDCowan NC. CT urography for hematuria. Nat Rev Urol. 2012 Mar 13;9(4):218-26. doi: 10.1038/nrurol.2012.32. PMID 22410682
BACKGROUNDCowan 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. PMID 17428251
BACKGROUNDJanisch 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. PMID 31321509
BACKGROUNDTakahashi 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. PMID 20171676
BACKGROUNDFreudenberg LS, Beyer T. Subjective perception of radiation risk. J Nucl Med. 2011 Dec;52 Suppl 2:29S-35S. doi: 10.2967/jnumed.110.085720. PMID 22144552