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Upper Tract Urinary CarcinomaDEDUCTNCT05349812

Detection of Disease in the Upper Tract

An observational study of Upper Tract Urinary Carcinoma, run by Pacific Edge Limited.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Upper Tract Urinary Carcinoma
How many people
0 participants
Where
No sites listed yet
Study dates
Nov 2022to Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: This is a single arm observational study prospectively recruiting eligible patients with no apparent bladder cancer following white light cystoscopy but have positive or suspicious urine cytology or imaging results.

Who may be able to join

  • Suspected to have UTUC following negative cystoscopy but positive or suspicious imaging and/or urine cytology.
  • Under surveillance for UTUC following a previous confirmed diagnosis of UTUC
  • Able to provide a voided urine sample of the required 30 ml minimum volume
  • Able to give written consent
  • Able and willing to comply with study requirement
  • Aged 18 years or older

Who cannot join

  • Prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection
  • Total cystectomy of the bladder with bowel urinary diversion
  • Pregnancy

About this study

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

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.

Read the detailed 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.

Keywords
observational upper urinary tract carcinoma hematuria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study startNov 2022 (estimated)
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Why it stopped: Sponsor focusing on completion of other studies at this time.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349812
Sponsor's protocol ID
Pacificedgedx
Acronym
DEDUCT
Status last verified
Apr 2022
First submitted
18 Apr 2022
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 20825397

  • 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.

    PubMed 19434668

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

    PubMed 22410682

  • 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.

    PubMed 17428251

  • 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.

    PubMed 31321509

  • 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.

    PubMed 20171676

  • Freudenberg LS, Beyer T. Subjective perception of radiation risk. J Nucl Med. 2011 Dec;52 Suppl 2:29S-35S. doi: 10.2967/jnumed.110.085720.

    PubMed 22144552

  • 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.

    PubMed 18662560

  • 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.

    PubMed 19083224

  • 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.

    PubMed 18566177

  • 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.

    PubMed 17467608

  • 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.

    PubMed 21320275

  • 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.

    PubMed 30417563

  • 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.

    PubMed 20643443

  • 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.

    PubMed 25888331

Questions about this trial

What is this clinical trial studying?

An observational study of Upper Tract Urinary Carcinoma, run by Pacific Edge Limited.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance of Cxbladder for the detection of Upper Tract Urothelial Carcinoma (UTUC) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349812, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.

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