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

NCT05043662 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2021-09-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Chuangliang Xu, M.D., Ph.D · Changhai Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-10-01
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043662 on ClinicalTrials.gov