NCT05043662

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 110 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Urothelial Carcinoma
• Diagnoses Disease
• Ureter Cancer
• IMAGE
• Cytology

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	UroCAD assay, CTU examination and urine cytology	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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-01
• Completion: 2022-12-30
• First posted: 2021-09-14
• Last updated: 2021-09-14

Locations

1 site across 1 country: China