Status:

UNKNOWN

A Prospective, Multi-centre, Single-blinded Study of UroCAD for Urothelial Carcinoma Diagnosis and Follow-up

Lead Sponsor:

Changhai Hospital

Collaborating Sponsors:

RenJi Hospital

The First Affiliated Hospital of Soochow University

Conditions:

Urothelial Carcinoma

Eligibility:

All Genders

18+ years

Brief Summary

Urothelial carcinoma (UC) is common malignancy and is considered to be one of the costliest cancers. The traditional diagnostic methods of UC present with some shortcomings. For example, the specifici...

Detailed Description

The traditional diagnostic methods of UC include CT urography (CTU) and cystoscopy. To access the upper urinary tract, CTU is commonly used. The sensitivity for detecting upper tract urothelial cancer...

Eligibility Criteria

Inclusion

  • Patients diagnosed with urothelial carcinoma and planned to undergo surgery
  • Cancer patient with urine cytology test result
  • Cancer patient willing to provide urine sample before the surgery, 3 months after surgery, 6 months after surgery, 12 month after surgery, 15 months after surgery, 18 months after surgery, 21 months after surgery, 24 months after surgery, and willing to provide patient information.
  • 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

  • Age under 18 years
  • 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.
  • Patient with late-stage uremia and need regular dialysis.
  • Patient with cancer other than urothelial carcinoma.

Key Trial Info

Start Date :

January 17 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 30 2022

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT04432909

Start Date

January 17 2020

End Date

June 30 2022

Last Update

September 16 2021

Active Locations (1)

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1

Changhai Hospital

Shanghai, Shanghai Municipality, China, 200433