UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.

Brief Title

UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.

Official Title

A Prospective, Single-blinded Study of UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.

Brief Summary

      Upper tract urothelial carcinoma (UTUC) diagnosis include urography using computed tomography
      urography (CTU) or urography using MRI (MRU). The sensitivity of CTU decreases substan¬tially
      with decreasing lesion size. Other drawbacks of CTU include the radiation exposure and
      potential adverse effects in patients with allergic reactions or pre-existing renal
      impairment. In terms of urine cytology, the major drawbacks of urine cytology are low
      sensitivity and highly dependent of the experience and skills of the cytopathologist. We here
      intended to investigate whether UroCAD can be added in the diagnostic work-up of UTUC
      patient, and improve the accuracy of predicting UTUC before surgery.
    

Detailed Description

      The recommendations for imaging in UTUC diagnosis include urography using CTU or MRU. In the
      standard diag¬nostic work up, urine cytology and a cystoscopy to rule out a concomitant
      bladder tumor are also advised. In addition, diagnostic ureterorenoscopy and biopsy are
      advised in patients in whom the findings of these pro¬cedures could influence treatment
      decisions, The sensitivity of CTU decreases substan¬tially with decreasing lesion size. For
      polypoid tumors of 5-10 mm maximal diameter, CTU has a high sensitivity and specificity, but
      sensitivity decreases to 89% for lesions <5 mm and further to 40% for lesions <3 mm. Flat
      lesions are even more difficult to diagnose. Other drawbacks of CTU include the radiation
      exposure and the need for intravenous contrast media with accompa¬nying potential adverse
      effects in patients with allergic reactions or pre-existing renal impairment. In terms of
      urine cytology, the major drawbacks of urine cytology tests: the sensitivity of positive
      urine cytology is highly dependent on tumor grade and decreases to 12% for low-grade tumors
      and 15% for non-invasive stage Ta tumors. Hence, low-grade urothelial tumors cannot be
      reliably detected by urine cytology. Finally, the accuracy of the cytology findings is highly
      dependent of the experience and skills of the cytopathologist. Our previous study has proved
      that UroCAD, which is able to detect chromosomal aberrations of the urine exfoliated cells,
      is a reliable method in diagnosing urothelial carcinoma with sensitivity and specificity of
      82.5% and 96.9%, respectively. But its potential role in diagnosis of UTUC in combination
      with CTU and cytology hasn't been assessed yet and the accuracy of UroCAD in detecting UTUC
      still need to be further validated. We here intended to investigate whether UroCAD can be
      added in the diagnostic work-up of UTUC patient, and improve the accuracy of predicting UTUC
      before surgery.
    

Study Type

Observational

Primary Outcome

Sensitivity and Specificity of urinalysis by UroCAD assay combined with CTU and cytology

Secondary Outcome

 Identification of the correlation between the level of CNV and the grade of the tumor sample

Condition

Urothelial Carcinoma

Intervention

UroCAD assay, CTU examination and urine cytology

Study Arms / Comparison Groups

 Urothelial carcinoma group

Description:  The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. CTU and cytology will be performed according to the routine of clinical practice (N=80).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

110

Start Date

September 1, 2021

Completion Date

December 30, 2022

Primary Completion Date

October 1, 2022

Eligibility Criteria

        Inclusion Criteria:

        Patients suspected with UTUC and planned to undergo surgery such as such ureteroscopy or
        radical nephroureterectomy.

        Participants without any tumor disease and willing to attend the study by providing morning
        urine.

        Male or female patients aged >= 18 years. Participants signed informed consent form.

        Exclusion Criteria:

        Individuals unwilling to sign the consent form or unwilling to provide morning urine for
        test or unwilling to provide the medical record.

        Patient already received suprapubic cystostomy or urethral catheterization. Participants
        with late-stage uremia and need regular dialysis. Participants with reasons like elevated
        serum creatinine, allergy to intravenous CT contrast media et al, and unable to undergo
        CTU.

        Patient with cancer other than urothelial carcinoma.
      

Gender

All

Ages

18 Years - N/A

Contacts

Chuangliang Xu, M.D., Ph.D, 86-021-31161718, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT05043662

Organization ID

UroCAD-UTUC

Responsible Party

Principal Investigator

Study Sponsor

Changhai Hospital

Study Sponsor

Chuangliang Xu, M.D., Ph.D, Study Director, Changhai Hospital

Verification Date

September 2021