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

NCT04432909 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-09-16

No results posted yet for this study

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 specificity of CTU remains low while cystoscopy is invasive and expensive. Therefore, a noninvasive diagnostic method with high accuracy is urgently needed. 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 UC with sensitivity and specificity of 82.5% and 96.9%, respectively. But its potential in UC patient follow-up hasn't been assessed yet and the the accuracy of UroCAD in detecting UC still need to be further validated. The investigators here intended to investigate whether UroCAD can be used in UC patient follow-up and further validate the accuracy of UroCAD in diagnosing UC.

Conditions

Interventions

DIAGNOSTIC_TEST

The level of CNV

The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. And the patient will be followed for up to 2 years.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Zhejiang Provincial People's Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Tianjin Medical University Second Hospital

    collaborator OTHER

  • Qilu Hospital of Shandong University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Xibei Hospital

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Chuanliang Xu, M.D.,Ph.D. · Changhai Hospital, Shanghai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2022-01-30
Completion
2022-06-30

Countries

  • China

Study Locations

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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 NCT04432909 on ClinicalTrials.gov