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 Information
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
Administrative Informations
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